Medical kit for constricting tissue or a bodily orifice, for example, a mitral valve

ABSTRACT

A device, kit and method may include or employ an implantable device (e.g., annuloplasty implant) and a plurality of tissue anchors. The implantable device is positionable in a cavity of a bodily organ (e.g., a heart) and operable to constrict a bodily orifice (e.g., a mitral valve). Each of the tissue anchors may be guided into precise position by an intravascularly or percutaneously techniques. Constriction of the orifice may be accomplished via a variety of structures, for example an articulated annuloplasty ring, the ring attached to the tissue anchors. The annuloplasty ring may be delivered in an unanchored, generally elongated configuration, and implanted in an anchored generally arched, arcuate or annular configuration. Such may approximate the septal and lateral (clinically referred to as anterior and posterior) annulus of the mitral valve, to move the posterior leaflet anteriorly and the anterior leaflet posteriorly, thereby improving leaflet coaptation to reduce mitral regurgitation.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 13/421,677, filed on Mar. 15, 2012, which claims benefit under35 U.S.C. 119(e) to U.S. Provisional Patent Application No. 61/467,883,filed on Mar. 25, 2011, the entire disclosure of both of suchapplications is hereby incorporated herein by reference.

BACKGROUND

1. Field

This disclosure is generally related to percutaneous or minimallyinvasive surgery, and more particularly to percutaneously deployedmedical devices suitable for constricting tissue or a bodily orifice,such as a mitral valve.

2. Description of the Related Art

Cardiac surgery was initially undertaken by performing a sternotomy, atype of incision in the center of the chest, which separates the sternum(chest bone) to allow access to the heart. In the previous severaldecades, more and more cardiac operations are performed using apercutaneous technique, which is a medical procedure where access toinner organs or other tissue is gained via a catheter.

Percutaneous surgeries benefit patients by reducing surgery risk,complications, and recovery time. However, the use of percutaneoustechnologies also raises some particular challenges. Medical devicesused in percutaneous surgery need to be deployed via narrow tubes calledcatheter sheaths which significantly increase the complexity of thedevice structure. As well, doctors do not have direct visual contactwith the medical tools used once they are placed within the body, andpositioning the tools correctly and operating the tools successfully canoften be very challenging. Various catheters can be deployed through acatheter sheath in percutaneous surgical applications.

One example of where percutaneous medical techniques are starting to beused is in the treatment of a heart disorder called mitralregurgitation. Mitral regurgitation is a condition in which blood flowsbackward from the left ventricle into the left atrium. The mitralapparatus is made up of four major structural components and includesthe annulus, the two leaflets, the chordae and the papillary muscles.Improper function of anyone of these structures, alone or in combinationcan lead to mitral regurgitation. Annular dilation is a major componentin the pathology of mitral regurgitation regardless of cause and ismanifested in mitral regurgitation related to dilated cardiomyopathy andin chronic mitral regurgitation due to ischemia.

The mitral valve is intended to prevent the undesired flow of blood fromthe left ventricle into the left atrium when the left ventriclecontracts. In a normal mitral valve, the geometry of the mitral valveensures the cusps overlay each other to preclude the regurgitation ofblood during left ventricular contraction and thereby prevent elevationof pulmonary vascular pressures and resultant symptoms of shortness ofbreath. Studies of the natural history of mitral regurgitation havefound that totally asymptomatic patients with severe mitralinsufficiency usually progress to severe disability within 5 years.

At present, treatment consists of either mitral valve replacement orrepair. Both methods require open heart surgery. Replacement can beperformed with either mechanical or biological valves and isparticularly suitable when one of the mitral cusps has been severelydamaged or deformed. The mechanical valve carries the risk ofthromboembolism and requires anticoagulation with all of its potentialhazards, whereas the biological prosthesis suffers from limiteddurability. Another hazard with replacement is the risk of endocarditis.These risks and other valve related complications are greatly diminishedwith valve repair. Mitral valve repair is theoretically possible if themitral valve leaflets are structurally normal but fail to appropriatelycoapt because of annular dilatation or papillary muscle dysfunction, orboth. Various surgical procedures have been developed to improvecoaptation of the leaflet and to correct the deformation of the mitralvalve annulus and retain the intact natural heart valve function. Theseprocedures generally involve reducing the circumference of the posteriormitral leaflet annulus (lateral annulus) where most of the dilatationoccurs. The annulus of the anterior leaflet (septal annulus) does notgenerally dilate because it is anchored to the fibrous skeleton at thebase of the heart. Such techniques, known as mitral annuloplasty,typically suture a prosthesis around the base of the valve leafletsshortening the lateral annulus to reshape the mitral valve annulus andminimize further dilation. Different types of mitral annuloplastyprostheses have been developed for use in such surgery. In general, suchprostheses are annular or partially annular shaped and may be formedfrom rigid or flexible material.

Mitral valve surgery requires an extremely invasive approach thatincludes a chest wall incision, cardiopulmonary bypass, cardiac andpulmonary arrest, and an incision on the heart itself to gain access tothe mitral valve. Such a procedure is expensive, requires considerabletime, and is associated with high morbidity and mortality. Due to therisks associated with this procedure, many of the sickest patients aredenied the potential benefits of surgical correction of mitralregurgitation. In addition, patients with moderate, symptomatic mitralregurgitation are denied early intervention and undergo surgicalcorrection only after the development of cardiac dysfunction.Furthermore, the effectiveness of such procedures is difficult to assessduring the procedure and may not be known until a much later time.Hence, the ability to make adjustments to or changes in the prosthesisfunction to obtain optimum effectiveness is extremely limited.Correction at a later date would require another open heart procedure.

In an attempt to treat mitral regurgitation without the need forcardiopulmonary bypass and without opening the chest, percutaneousapproaches have been devised to repair the valve or place a correctingapparatus for correcting the annulus relaxation. Such approaches makeuse of devices which can be generally grouped into two types: 1) devicesdeforming (mainly shortening) the coronary sinus; and 2) devices pullingtogether two anchor points in order to affect the mitral valve, one ofthe anchor points can be the coronary sinus (typically using a wire thatis pulled and secured).

Neither approach emulates the current “gold standard” in mitral valverepair—annuloplasty using an open or closed ring. Both approaches sufferfrom several problems as a result of attempting to reshape the mitralannulus using an alternative method. Devices that deform the coronarysinus, while suitable for percutaneous procedures, are not effective incontrolling the leakage of the mitral valve as the forces are notapplied from the correct opposite sides of the valve, which are thelateral annulus and the septal annulus. The devices of the second typeare not easily adapted to a percutaneous procedure. In order to achieveshortening in the direction connecting the lateral annulus to the septalannulus the anchor points should be located along this direction, sopulling them together will affect the desired direction of shortening.Pulling applied along a different direction will distort the mitralvalve but will not achieve the optimal approximation of the twoleaflets.

Thus, there is a need for methods and apparatus that enable the abilityto create a mitral annuloplasty that applies forces from various desireddirections via a percutaneous or intravascular procedure.

BRIEF SUMMARY

The subject of the present application is a medical device withcapabilities for percutaneous deployment and annulus shape modificationand a superior method for constricting tissue or a bodily orifice, suchas the mitral valve, tricuspid valve, or aortic valve via such device.The device may enable methods that enable an open (i.e., split) ring tobe anchored to tissue in the vicinity of an orifice or annulus and mayenable a change in the shape of said annulus by the anchored ring.Reference throughout this specification is made to cardiac surgery, butthe methods and apparatus described herein may also be used in gastricsurgery, bowel surgery, or other surgeries in which tissue may be drawntogether. The methods and apparatus described herein may also be used todraw or hold tissue not part of an orifice or annulus together. Themethods and apparatus described herein may be used in minimally invasivesurgery as well as intravascular or percutaneous surgery. Otheradvantages will become apparent from the teaching herein to those ofskill in the art.

An implant kit may be summarized as including an implant member and aplurality of tissue anchors. Each of the plurality of tissue anchors isat least partially embeddable into tissue at a respective location aboutan orifice within a body during an implant procedure. The implant memberis reconfigurable between a delivery configuration in which the implantmember is manipulable to a size and dimension to be deliveredpercutaneously to the tissue within the body, and a deployedconfiguration in which the implant member forms a structure sufficientlyrigid to affect a shape of the orifice in the tissue. The implant memberincludes a plurality of segments, each of the segments physicallycoupled to another of the plurality of segments. The implant memberincludes a plurality of tissue anchor receivers, each of the tissueanchor receivers arranged to selectively receive a respective one of theplurality of tissue anchors. The implant member includes at least afirst pivot joint comprising a first pivot pin and a first pivot axis.The first pivot pin of the first pivot joint is arranged to pivotallycouple a first set of two or more of the segments together, each segmentin the first set of two or more of the segments arranged to pivot aboutthe first pivot axis when the implant member is moved between thedelivery configuration and the deployed configuration, the first pivotjoint arranged such that the first pivot axis intersects a minimumcylindrical volume containing a first one of the plurality of tissueanchors when the first one of the plurality of tissue anchors is securedto the implant member.

The first one of the plurality of tissue anchors may be received by afirst tissue anchor receiver of the plurality of tissue anchor receiverswhen the first one of the plurality of tissue anchors is secured to theimplant member. The first tissue anchor receiver may be arranged toimpede a portion of the first one of the plurality of tissue anchorsfrom moving along at least one direction when the first one of theplurality of tissue anchors is secured to the implant member, the atleast one direction having a directional component parallel to adirection that the first pivot axis extends along. The first tissueanchor receiver may be arranged to impede the portion of the first oneof the plurality of tissue anchors from moving perpendicularly to thefirst pivot axis when the first one of the plurality of tissue anchorsis secured to the implant member.

The first one of the plurality of tissue anchors may be embedded in thetissue when the first one of the plurality of tissue anchors is receivedby a first tissue anchor receiver of the plurality of tissue anchorreceivers. The first one of the plurality of tissue anchors may beembedded in the tissue when the first one of the plurality of tissueanchors is secured to the implant member. The implant kit may include atleast one implant guide line physically coupled to the first one of theplurality of tissue anchors to provide a physical path for the implantmember to the first one of the plurality of tissue anchors when thefirst one of the plurality of tissue anchors is embedded in the tissue,the implant member moveable along the physical path to a position wherethe implant member is secured to the first one of the plurality oftissue anchors. The implant member include at least one guide linereceiver, the at least one guide line receiver sized and dimensioned toreceive the at least one implant guide line.

The first pivot joint may be one of a plurality of pivot joints, each ofthe pivot joints including a respective pivot axis, and each of thepivot joints arranged to pivotally couple each of the segments togetherin a respective one of a plurality of sets of two or more of thesegments. Each tissue anchor of at least one of the plurality of tissueanchors may positioned such that a minimum cylindrical volume containinga respective tissue anchor of the at least one of the plurality oftissue anchors is not intersected by each of the pivot axes when theplurality of tissue anchors are secured to the implant member. Eachpivot axis may be parallel to another of the pivot axes. At least one ofthe pivot axes may not be parallel to another of the pivot axes.

Each of the plurality of tissue anchor receivers may include arespective at least one alignment surface arranged to guide a portion ofa respective one of the plurality of tissue anchors to a position wherethe respective one of the plurality of tissue anchors is securable tothe implant member. The respective at least one alignment surface ofeach of one or more of the plurality of tissue anchor receivers mayinclude a curved surface portion. The respective at least one alignmentsurface of each of one or more of the plurality of tissue anchorreceivers may include a tapered or conical surface portion. The at leastone alignment surface of the respective one of the plurality of tissueanchor receivers associated with the first one of the plurality oftissue anchors may be circumferentially arranged about an axis that issubstantially parallel to the first pivot axis of the first pivot joint.The at least one alignment surface of the respective one of theplurality of tissue anchor receivers associated with the first one ofthe plurality of tissue anchors may be circumferentially arranged aboutan axis that is collinear with the first pivot axis associated with thefirst pivot joint.

The implant kit may further include a biasing device, the biasing deviceapplying force to the first one of the plurality of tissue anchors whenthe first one of the plurality of tissue anchors is secured to theimplant member, the force applied along a direction having a directionalcomponent parallel to a direction that the first pivot axis associatedwith the first pivot joint extends along.

The implant kit may further include a coupler arranged to engage aportion of the first one of the plurality of tissue anchors to capture aportion of the implant member between the coupler and a second portionof the first one of the plurality of tissue anchors when the first oneof the plurality of tissue anchors is secured to the implant member, thesecond portion of the first one of the plurality of tissue anchorsembeddable into the tissue. The first one of the plurality of tissueanchors may be embedded in the tissue when the first one of theplurality of tissue anchors is secured to the implant member. Theimplant kit may further include at least one implant guide linephysically coupled to the first one of the plurality of tissue anchorsto provide a physical path for the coupler to the first one of theplurality of tissue anchors when embedded in the tissue, the couplermoveable along the physical path to a position where the coupler engagesthe portion of the first one of the plurality of tissue anchors whenembedded in the tissue to capture the portion of the implant memberbetween the coupler and the second portion of the first one of theplurality of tissue anchors. A portion of the coupler and the implantmember may be provided in a unitary structure.

The implant may further include a holder activatable between a freeconfiguration in which a first segment in the first set of two or moreof the segments is arranged to pivot about the first pivot axis alongeach of a first rotational direction towards a second segment in thefirst set of two or more of the segments and along a second rotationaldirection away from the second segment in the first set of two or moreof the segments, and a fixed configuration in which the first segment inthe first set of two or more of the segments is impeded from pivotingabout the first pivot axis along each of the first rotational directionand the second rotational direction with a greater resistance than whenthe holder is in the free configuration, wherein the first rotationaldirection and the second rotational direction are opposing rotationaldirections. A portion of the first segment in the first set of two ormore of the segments may be spaced relatively farther apart from aportion of the second segment in the first set of two or more of thesegments along an axis parallel to the first pivot axis when the holderis in the free configuration. The portion of the first segment in thefirst set of two or more of the segments may be spaced relatively closerto the portion of the second segment in the first set of two or more ofthe segments along the axis parallel to the first pivot axis when theholder is in the fixed configuration. The holder may include a pluralityof interlockable elements which are brought into interlocked engagementwhen the implant member is moved into the deployed configuration. Eachof the plurality of interlockable elements may include a trapezoidalshaped projection or a trapezoidal shaped recess.

The first segment in the first set of two or more of the segments may beimpeded from pivoting about the first pivot axis along the firstrotational direction towards the second segment in the first set of twoor more of the segments with a first resistance when the holder is inthe fixed configuration, and the first segment in the first set of twoor more of the segments may be impeded from pivoting about the firstpivot axis along the second rotational direction away from the secondsegment in the first set of two or more of the segments with a secondresistance when the holder is in the fixed configuration. Each of thefirst resistance and the second resistance may be provided at least inpart by the holder, and a magnitude of the second resistance may be lessthan a magnitude of the first resistance.

The first pivot joint may be arranged such that the first pivot axisintersects a surface of the first one of the plurality of tissue anchorswhen the first one of the plurality of tissue anchors is secured to theimplant member.

Various systems and methods may include combinations and subsets ofthose summarized above.

An implant kit may be summarized as including an implant member and aplurality of tissue anchors. The plurality of tissue anchors isconfigured to be at least partially embedded into tissue at respectivelocations about an orifice within a body during an implant procedure.The implant member is reconfigurable between a delivery configuration inwhich the implant member is manipulable to a size and dimension to bedelivered percutaneously to the tissue within the body, and a deployedconfiguration in which the implant member forms a structure sufficientlyrigid to affect a shape of the orifice in the tissue. The implant memberincludes a plurality of segments and a number of pivot joints, eachpivot joint including a respective pivot pin and a respective pivotaxis. The pivot pin of each pivot joint is arranged to pivotally coupleeach of the segments together in a respective one of a number of sets oftwo or more of the segments, at least one segment in each respective oneof the number of sets of two or more of the segments pivoting about therespective pivot axis of the pivot joint when the implant member ismoved between the delivery configuration and the deployed configuration.The implant member includes a plurality of tissue anchor receivers, eachtissue anchor receiver including at least one alignment surface arrangedto contact a portion of a respective one of the plurality of tissueanchors and align the portion of the respective one of the plurality oftissue anchors with respect to an alignment axis of the tissue anchorreceiver when the respective one of the plurality of tissue anchors issecured to the implant member. The portion of the respective one of theplurality of tissue anchors is impeded from moving along the alignmentaxis of the tissue anchor receiver to break contact with the at leastone alignment surface of the tissue anchor receiver when the respectiveone of the plurality of tissue anchors is secured to the implant member.The respective alignment axis of at least a first one of the pluralityof tissue anchor receivers is non-parallel with the respective pivotaxis of at least one of the number of pivot joints. The respectivealignment axis of at least a second one of the plurality of tissueanchor receivers is substantially parallel to the respective pivot axisof the at least one of the number of pivot joints.

The respective at least one alignment surface of each tissue anchorreceiver may be arranged to restrain or impede the portion of therespective one of the plurality of tissue anchors from moving along adirection having a directional component perpendicular to the respectivealignment axis of the tissue anchor receiver when the respective one ofthe plurality of tissue anchors is secured to the implant member.

At least one of the plurality of tissue anchors may be embedded in thetissue when the respective portion of the at least one of the pluralityof tissue anchors is aligned by the at least one alignment surface of arespective one of the plurality of tissue anchor receivers. At least oneof the plurality of tissue anchors may be embedded in the tissue whenthe at least one of the plurality of tissue anchors is secured to theimplant member. The implant kit may further include a number of implantguide lines, each of the number of implant guide lines physicallycoupled to the at least one of the plurality of tissue anchors when theat least one of the plurality of tissue anchors is embedded in thetissue to provide a physical path for the implant member to the at leastone of the plurality of tissue anchors. The implant member may bemoveable along the physical path to a position where the implant memberis secured to the at least one of the plurality of tissue anchors.

The number of pivot joints may include a plurality of pivot jointsarranged such that the respective pivot axes of at least two of theplurality of pivot joints are parallel with respect to one another. Thenumber of pivot joints may include a plurality of pivot joints arrangedsuch that the respective pivot axes of at least two of the plurality ofpivot joints are non-parallel with respect to one another.

The implant kit may further include a plurality of biasing devices, eachof the biasing devices biasing the segments together in a respective oneof the number of sets of two or more of the segments when the pluralityof tissue anchors are secured to the implant member. The implant kit mayfurther include a plurality of couplers, each coupler arranged to engagea respective first portion of a respective one of the plurality oftissue anchors to capture a portion of the implant member between thecoupler and a respective second portion of the respective one of theplurality of tissue anchors when the respective one of the plurality oftissue anchors is secured to the implant member, the respective secondportion of each of the plurality of tissue anchors may be embeddableinto the tissue.

The implant kit may further include a number of holders, each holderactivatable between a free configuration in which each segment in arespective one of the number of sets of two or more of the segments isarranged to pivot towards and away from another one of the segments inthe respective one of the number of sets of two or more of the segments,and a fixed configuration in which the segment in the respective one ofthe number of sets of two or more of the segments is impeded frompivoting towards and away from the another one of the segments in therespective one of the number of sets of two or more of the segments witha greater resistance than when the holder is in the free configuration.Each holder may include a respective plurality of interlockable elementswhich are brought into interlocked engagement when the implant member ismoved into the deployed configuration. Each of the plurality ofinterlockable elements may include a trapezoidal shaped projection or atrapezoidal shaped recess.

The respective alignment axis of at least the second one of theplurality of tissue anchor receivers may be collinear with therespective pivot axis of the at least one of the number of pivot joints.

Various systems and methods may include combinations and subsets ofthose summarized above.

An implant may be summarized as including an implant member and aplurality of tissue anchors. Each of the plurality of tissue anchors isat least partially embeddable in tissue at a respective location aboutan orifice within a body during an implant procedure. The implant memberis reconfigurable between a delivery configuration in which the implantmember is manipulable to a size and dimension to be deliveredpercutaneously to the tissue within the body, and a deployedconfiguration in which the implant member forms a structure sufficientlyrigid to affect a shape of the orifice in the tissue. The implant memberincludes a plurality of segments and a pivot joint including a pivotaxis. The pivot joint is arranged to pivotally couple two segments ofthe plurality of segments together. The implant member includes a holderactivatable between a free configuration in which the two segments arearranged to pivot towards and away from each other about the pivot axis,and a fixed configuration in which the two segments are impeded frompivoting towards and away from each other about the pivot axis with agreater resistance than when the holder is in the free configuration.The holder includes a plurality of interlockable elements positioned ininterlocked engagement when the holder is in the fixed configuration. Afirst one of the two segments is impeded with a first resistance frompivoting about the pivot axis along a first rotational direction towardsa second one of the two segments when the holder is in the fixedconfiguration, and the first one of the two segments is impeded with asecond resistance from pivoting about the pivot axis along a secondrotational direction away from the second one of the two segments whenthe holder is in the fixed configuration. The second rotationaldirection is opposite to the first rotational direction. Each of thefirst resistance and the second resistance is provided at least in partby the holder, and a magnitude of the second resistance is less than amagnitude of the first resistance.

The plurality of interlockable elements comprise a first set of theinterlockable elements having a plurality of projections and a pluralityof recesses, and a second set of the interlockable elements having aplurality of projections and a plurality of recesses. Each of theprojections in each of the first and the second sets of theinterlockable elements may be sized and dimensioned to be received by arespective one of the recesses in the other of the first and the secondsets of the interlockable elements when the first set of theinterlockable elements is moved relatively closer to the second set ofthe interlockable elements along a direction having a directionalcomponent parallel to a direction that the pivot axis extends along.

Each of the projections and recesses in the first set of theinterlockable elements and the first one of the two segments may beprovided in a first unitary structure. Each of the projections andrecesses in the second set of the interlockable elements and the secondone of the two segments may be provided in a second unitary structure.

Each of the projections in each of the first and the second sets of theinterlockable elements may be sized and dimensioned to be received by arespective one of the recesses in the other of the first and the secondsets of the interlockable elements when the plurality of interlockableelements are moved into interlocked engagement. Each of the projectionsand recesses in each of the first and the second sets of theinterlockable elements may be radially arranged about the pivot axis.The plurality of interlockable elements may be moved into interlockedengagement when a portion of the first one of the two segments is movedrelatively with respect to a portion of the second one of two segmentsalong an axis that is substantially parallel to the pivot axis. Thepivot joint may include a pivot pin, and the plurality of interlockableelements may be moved into interlocked engagement when at least one ofthe two segments is moved axially along the pivot pin to reduce adistance between the two segments. The first one of the two segments maybe axially positioned along the pivot pin relatively closer to thesecond one of the two segments on the pivot pin when the implant memberis in the deployed configuration, and the first one of the two segmentsmay be axially positioned along the pivot pin relatively farther fromthe second one of two segments when the implant member is in thedelivery configuration.

The implant may further include a biasing device arranged to apply aforce to bias the two segments together when the implant member is inthe deployed configuration, the force applied along a direction having adirectional component parallel to a direction that the pivot axisextends along. The implant may further include a coupler arranged tosecure the first one of the plurality of tissue anchors to the implantmember, at least the coupler and the biasing device provided in aunitary structure.

At least some of the projections in at least one of the first and thesecond sets of the interlockable elements may be shaped and sized forwedged engagement with at least some of the recesses in the other of thefirst and the second sets of the interlockable elements when the atleast one of the first and the second sets of the interlockable elementsis moved relatively closer to the other of the first and the second setsof the interlockable elements along a direction having a firstdirectional component parallel to a direction that the pivot axisextends along. At least one projection in the at least one of the firstand the second sets of the interlockable elements may include arespective pair of non-parallel opposing surfaces positioned to bewedged between two opposing surfaces of a respective one of the recessesin the other of the first and the second sets of the interlockableelements when the at least one of the first and the second sets of theinterlockable elements is moved relatively closer to the other of thefirst and the second sets of the interlockable elements along thedirection having the first directional component. A first surface of therespective pair of non-parallel opposing surfaces may be oriented withrespect to the first directional component by a greater angular amountthan a second surface of the respective pair of non-parallel opposingsurfaces. The second surface of the respective pair of non-parallelopposing surfaces may be oriented substantially parallel to the firstdirectional component.

The plurality of interlockable elements may be brought into wedgedengagement when a portion of the first one of the two segments is movedrelatively closer to a portion of the second one of two segments alongan axis that is substantially parallel to the pivot axis. The portion ofthe first one of the two segments may be positioned relatively closer tothe portion of the second one of the two segments along the axis that issubstantially parallel to the pivot axis when the implant member is inthe deployed configuration than when the implant member is in thedelivery configuration.

The plurality of interlockable elements may be arranged within theholder to interlock with one another when the implant member is movedinto the deployed configuration. At least one recess in the at least oneof the first and the second sets of the interlockable elements mayinclude a respective pair of nonparallel opposing surfaces positioned tobe wedged against two opposing surfaces of a respective one of theprojections in the other of the first and the second sets of theinterlockable elements when the at least one of the first and the secondsets of the interlockable elements is moved relatively closer to theother of the first and the second sets of the interlockable elementsalong the direction having the first directional component. A firstsurface of the respective pair of non-parallel opposing surfaces may beoriented with respect to the first directional component by a greaterangular amount than a second surface of the respective pair ofnonparallel opposing surfaces.

Various systems and methods may include combinations and subsets ofthose summarized above.

An implant kit may be summarized as including an implant member and aplurality of tissue anchors. Each of the plurality of tissue anchors isat least partially embeddable into tissue at a respective location aboutan orifice within a body during an implant procedure. The implant memberis reconfigurable between a delivery configuration in which the implantmember is manipulable to a size and dimension to be deliveredpercutaneously to the tissue within the body, and a deployedconfiguration in which the implant member forms a structure sufficientlyrigid to affect a shape of the orifice in the tissue. The implant memberincludes a plurality of segments and a plurality of tissue anchorreceivers. Each tissue anchor receiver includes at least one alignmentsurface arranged to contact a portion of a respective one of theplurality of tissue anchors and position the portion of the respectiveone of the plurality of tissue anchors at a location where the one ofthe plurality of tissue anchors is securable to the implant member.

The implant member includes at least a first pivot joint comprising afirst pivot member. The first pivot joint is arranged to pivotallycouple a first set of two or more of the segments together, at leastsome of the segments in the first set of two or more of the segmentsarranged to turn about the first pivot member when the implant member ismoved between the delivery configuration and the deployed configuration.The first pivot member and a first one of the tissue anchor receiversare provided in a unitary structure.

The first pivot member may be fixedly coupled to one of the segments inthe first set of two or more of the segments. At least one segment inthe first set of two or more of the segments may be slidably andpivotably coupled to the first pivot member. The at least one segment inthe first set of two or more of the segments may be arranged totranslate along, and turn about, the first pivot member when the implantmember is moved between the delivery configuration and the deployedconfiguration. The first pivot member may include at least oneobstruction positioned to capture the at least one segment in the firstset of two or more of the segments on the first pivot member.

The respective at least one alignment surface of the first one of thetissue anchor receivers may be radially spaced apart from a pivot axisof the first pivot joint by a different radial distance than a surfaceof the first pivot member contacted by the at least some of the segmentsin the first set of two or more of the segments. The respective at leastone alignment surface of the first one of the tissue anchor receiversmay include a tapered surface portion.

The implant member may include a plurality of interlockable elementsarranged about a pivot axis of the first pivot joint, a first set of theinterlockable elements arranged to interlock with a second set ofinterlockable elements when the implant member is in the deployedconfiguration.

Various systems and methods may include combinations and subsets ofthose summarized above.

An implant kit may be summarized as including an implant member and aplurality of tissue anchors. Each of the plurality of tissue anchors isat least partially embeddable into tissue at a respective location aboutan orifice within a body during an implant procedure. The implant memberis reconfigurable between a delivery configuration in which the implantmember is manipulable to a size and dimension to be deliveredpercutaneously to the tissue within the body, and a deployedconfiguration in which the implant member forms a structure sufficientlyrigid to affect a shape of the orifice in the tissue. The implant memberincludes a plurality of rigid portions and at least one bendable portionarranged to pivotally couple at least one of the rigid portions with atleast another of the rigid portions. The implant member includes aplurality of tissue anchor receivers. Each tissue anchor receiverincludes at least one alignment surface arranged to contact a portion ofa respective one of the plurality of tissue anchors and position theportion of the respective one of the plurality of tissue anchors at alocation where the one of the plurality of tissue anchors is securableto the implant member. At least a first one of the plurality of tissueanchor receivers is located in one of the plurality of rigid portionsand at least a second one of the plurality of tissue anchor receiverslocated in the at least one bendable portion.

Various systems and methods may include combinations and subsets of allthose summarized above.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, identical reference numbers identify similar elementsor acts. The sizes and relative positions of elements in the drawingsare not necessarily drawn to scale. For example, the shapes of variouselements and angles are not drawn to scale, and some of these elementsare arbitrarily enlarged and positioned to improve drawing legibility.Further, the particular shapes of the elements as drawn are not intendedto convey any information regarding the actual shape of the particularelements, and have been solely selected for ease of recognition in thedrawings.

FIG. 1 is a schematic diagram of a medical device system according toone illustrated embodiment, including an implantable device and a toolwith a control handle, tissue anchors, and anchor guide mechanism thatis operable to implant the implantable device.

FIG. 2 is a cutaway diagram of a heart showing an implantable medicaldevice implanted in tissue therein according to one illustratedembodiment, the implantable device percutaneously placed in a leftatrium of the heart.

FIG. 3 is a diagram showing an example of a helical tissue anchoraccording to one illustrated embodiment.

FIG. 4A is an isometric partial view showing an example of amulti-barbed tissue anchor with resilient barbs retained by aconstriction tube according to one illustrated embodiment.

FIG. 4B is an isometric partial view showing an example of amulti-barbed anchor with the resilient barbs free of the constrictiontube and exposed.

FIG. 5A is a front elevational view showing a helical tissue anchorembedded in tissue according to one illustrated embodiment.

FIG. 5B is a front elevational view showing a barbed tissue anchorembedded in tissue according to one illustrated embodiment.

FIG. 5C is a front elevational view showing a barbed tissue anchor withan integral guide line such as a guide wire according to anotherillustrated embodiment, the tissue anchor embedded in tissue.

FIG. 5D is a front elevational view showing a barbed tissue anchor witha unitary guide line such as a guide wire according to a furtherillustrated embodiment, the tissue anchor embedded in tissue.

FIG. 5E is a front elevational view showing a grapple tissue anchorembedded in tissue according to one illustrated embodiment.

FIG. 6A is an elevational view showing a tissue anchor movably receivedon a guided member according to one illustrated embodiment.

FIG. 6B is an elevational view showing a tissue anchor movably receivedon a guided rail according to another illustrated embodiment.

FIGS. 7A-7C are sequential elevational views showing a helical tissueanchor movably received on a guided member penetrating tissue at threesuccessive intervals of time according to one illustrated embodiment.

FIGS. 8A and 8B are sequential elevational views showing a multi-barbedtissue anchor movably received on a guided member penetrating tissue attwo successive intervals of time according to one illustratedembodiment.

FIGS. 8C through 8F are sequential elevational views showing amulti-barbed tissue anchor movably guided via a guided memberpenetrating tissue at four successive intervals of time according to oneillustrated embodiment.

FIG. 9 is an isometric view of an anchor guide frame according to oneillustrated embodiment.

FIG. 10 is a side elevational view of an anchor guide frame compressedinto a sheath according to one illustrated embodiment.

FIG. 11 is an isometric view of an expanded anchor guide frame accordingto one illustrated embodiment.

FIG. 12 is an isometric view showing a distal end of a medical devicesystem according to one illustrated embodiment

FIG. 13 is a cutaway diagram of a heart showing an example of tissueanchors secured in a mitral valve annulus according to one illustratedembodiment.

FIG. 14 is a cutaway diagram of a heart showing an example of tissueanchors and a cable used to constrict a mitral valve annulus accordingto one illustrated embodiment.

FIGS. 15A and 15B are cross-sectional views of a tool to secure a cableof an implantable device that constricts a bodily orifice at twosuccessive intervals of time illustrating a time prior to cutting thecable and a time when the cable is being cut according to oneillustrated embodiment.

FIGS. 16A and 16B are sequential isometric views showing a portion of acatheter with side slots according to one illustrated embodiment.

FIG. 17 is a cross-sectional partial view of a mechanism according toone illustrated embodiment for holding a tissue anchor captive.

FIGS. 18A and 18B are successive side elevational views of a mechanismaccording to one illustrated embodiment for restricting a tissue anchorfrom release until the tissue anchor is fully embedded in tissue.

FIG. 19A is an isometric view of an implant member according to oneillustrated embodiment, the implant member shown in a deliveryconfiguration.

FIG. 19B is a top plan view of the implant member of FIG. 19A shown inthe delivery configuration.

FIG. 19C is an isometric view of the implant member of FIGS. 19A and19B, the implant member shown in an implantable or deployedconfiguration.

FIG. 19D is a front elevational view of the implant member of FIGS.19A-19C, shown in the implantable or deployed configuration.

FIG. 20A is an isometric view of an implant member according to anotherillustrated embodiment, the implant member shown in a deliveryconfiguration.

FIG. 20B is a top plan view of the implant member of FIG. 20A shown inthe delivery configuration.

FIG. 20C is an isometric view of the implant member of FIGS. 20A and20B, the implant member shown in an implantable configuration.

FIG. 20D is a front elevational view of the implant member of FIGS.20A-20C, shown in the implantable configuration.

FIG. 20E is a top plan view showing an implant cross member, accordingto one illustrated embodiment.

FIG. 21A is an isometric view of a fastener that fastens to a guideline, according to one illustrated embodiment.

FIG. 21B is a cross-sectional view of the fastener and guide line ofFIG. 21A.

FIG. 22A is an isometric view of a fastener that fastens a guide line toa tissue anchor, according to another illustrated embodiment.

FIG. 22B is a cross-sectional view of the fastener, guide line andtissue anchor of FIG. 22A.

FIG. 22C is an isometric view of an implant member that has singlepiece, unitary part fasteners that fastens a guide line to a tissueanchor, according to another illustrated embodiment.

FIGS. 23A-23T are sequential schematic diagrams showing an implantprocedure according to one illustrated embodiment, which includesplacement of tissue anchors via an anchor guide frame at selectedlocations in an annulus surrounding a mitral valve of a left atrium of aheart and the securement of an implant member to the annulus via thetissue anchors.

FIG. 23U is a schematic diagram showing an implant member in the form ofan annuloplasty ring attached to an annulus of a mitral valve via tissueanchors, guide wires and fasteners, according to one illustratedembodiment.

FIG. 24A is an isometric view of an implant member according to anotherillustrated embodiment, the implant member shown in a deliveryconfiguration.

FIG. 24B is an isometric view of the implant member of FIG. 24A shownmated with a plurality of tissue anchors.

FIG. 24C shows a plurality of tissue anchors embedded in a tissueaccording to an illustrated embodiment.

FIG. 24D shows an implant member coupled with the embedded tissueanchors of FIG. 24C.

FIG. 24E is a sectional exploded view of a portion of the implant memberof FIGS. 24A and 24B prior to a mating with an embedded tissue anchor.

FIG. 24F is a sectional view of a portion of the implant member of FIGS.24A and 24B mated with an embedded tissue anchor.

FIG. 24G is an exploded isometric view of a portion of the implantmember of FIG. 24A and a grapple tissue anchor.

FIG. 24H is an isometric view of a portion of the implant member of FIG.24A mated with a grapple tissue anchor.

FIG. 25A is an isometric view of an implant member in a deliveryconfiguration according to one illustrated embodiment.

FIG. 25B is an isometric view of the implant member of FIG. 25A, theimplant member shown in a deployed configuration physically coupled to anumber of tissue anchors.

FIG. 25C is a partially sectioned view of the implant member of FIGS.25A-25B, the implant member shown positioned between the deliveryconfiguration and the deployed configuration, positioned to bephysically coupled to the tissue anchors.

FIG. 25D is a partially sectioned view of the implant member of FIGS.25A-25B, the implant member shown in the deployed configuration,physically coupled to the tissue anchors.

FIG. 25E is an exploded isometric view of the implant member of FIGS.25A-25B, the implant member shown in the deployed configuration alongwith the tissue anchors.

FIG. 25F is an exploded view of a portion of the implant member of FIGS.25A-25B, the implant member shown in the deployed configuration alongwith the tissue anchors.

DETAILED DESCRIPTION

In the following description, certain specific details are set forth inorder to provide a thorough understanding of various embodiments of theinvention. However, one skilled in the art will understand that theinvention may be practiced without these details. In other instances,well-known structures have not been shown or described in detail toavoid unnecessarily obscuring descriptions of the embodiments of theinvention.

Reference throughout this specification to “one embodiment” or “anembodiment” or “an example embodiment” or “an illustrated embodiment”means that a particular feature, structure or characteristic describedin connection with the embodiment is included in at least one embodimentof the present invention. Thus, the appearances of the phrases such as“in one embodiment” or “in an embodiment” in various places throughoutthis specification are not necessarily all referring to the sameembodiment. Furthermore, the particular features, structures, orcharacteristics may be combined in any suitable manner in one or moreembodiments.

As used in this specification and the appended claims, the singularforms “a,” “an,” and “the” include plural referents unless the contentclearly dictates otherwise. It should also be noted that the term “or”is generally employed in its sense including “and/or” unless the contentclearly dictates otherwise.

The headings provided herein are for convenience only and do notinterpret the scope or meaning of the claimed invention.

Overview of Device and Orifice Constriction Methods

Various embodiments of medical apparatus which are percutaneously orintravascularly deployed and may be used for constricting a bodilyorifice are described herein.

FIG. 1 shows a medical device system 100 including an implantable device115 and tool 116 to implant the implantable device 115, according to oneillustrated embodiment.

The tool 116 of the medical device system 100 may be used to deploy theimplantable device 115 having tissue anchors 107 and a flexible cable111. The tissue anchors 107 may be secured to the annulus of an orificeand the flexible cable 111 may be used to constrict the orifice bypulling the tissue anchors 107 inward. The tool 116 of the medicaldevice system 100 includes a flexible anchor guide frame 108 that may beused to guide tissue anchors 107 of the implantable device 115 to targetpositions on the orifice annulus. The anchor guide frame 108 may be madeof a material such as Nitinol. The anchor guide frame 108 shown in FIG.1 includes three guide members, for instance guide wires 112—one guidemember for each of the tissue anchors 107 shown. The guide frame 108 mayinclude a different number of guide members or arms (e.g., guide wiresor guide rails) 112 if more tissue anchors are desired. The guidemembers 112 shown preferably have hinges 113 and may be connected withsmall loops 109. The hinges 113 and loops 109 enable the anchor guideframe 108 to fold up to fit inside a catheter and to expand to extendacross an orifice. Both the hinges 113 and loops 109 may be replaced byother mechanisms or structures that enable bending or compression. Thetool 116 of the medical device system 100 typically has an articulationmechanism 106 (e.g., a plurality of articulation joints) that enablescorrectly orienting the anchor guide frame 108 during deployment oftissue anchors 107. The articulation mechanism 106 is preferably able tobend in various directions. The tool 116 of the medical device system100 may include control knobs 103 and 104 which may be used to controlthe bending of the articulation mechanism 106 via cables that arecarried in long flexible tube 105.

Long flexible tube 105 extends from the articulation mechanism 106 to amedical device control mechanism 114 located at a proximal end of thecatheter. Control mechanism 114 may include control knobs 103 and 104,elongated release members (e.g., rods or wires) 101, push tubes 102, andguide wires 112. Additional controls may be included in otherembodiments. The flexible tube 105 may have multiple lumens. Multi-lumenpush tubes 102, guide members (e.g., guide wires) 112, release members101, cable 111, and other mechanisms may be carried in flexible tube105. In the illustrated embodiment, each push tube 102 has two lumens. Aguide wire 112 is carried in a first lumen and a release member 101 iscarried in a second lumen. Tissue anchors 107 are attached at distaltips of release members 101. The tissue anchor 107 may be inserted intothe annulus of an orifice by advancing the push tube 102 along the guidemember 112 and advancing or rotating the release member 101 carried inthe push tube 102 at the same rate. The tissue anchor 107 may advancepast the hinge 113 and embed into the annulus of the orifice to beconstricted while in an unretracted configuration. Once the tissueanchor 107 is embedded, the release member 101 attached to the anchormay be retracted while the push tube 102 is held in place in a retractedconfiguration. Retraction of the release member 101 causes the tissueanchor 107 to detach from the distal tip of the release member 101 andremain embedded in the tissue at least proximate a desired location.Other embodiments may use different methods or structures, or both torelease the tissue anchors 107.

FIG. 2 shows an implantable device 207, 210 implantable in a portion ofa heart to constrict a bodily orifice, for example a mitral valve of theheart, according to one illustrated embodiment.

A portion of the medical device 207, 210 may be percutaneously and/orintravascularly inserted into a portion of a heart 212, for example in aleft atrium 206 of the heart 212. In this example embodiment, a flexibleanchor guide frame 214 and implantable device are delivered via acatheter 202 inserted via the inferior vena cava 204 and penetrating thetransatrial septum 213 from a right atrium 203. The catheter 202 ispreferably less than 8 mm in diameter.

The flexible anchor guide frame 214 expands after being delivered viathe catheter 202 into a shape that preferably enables the tissue anchors207 of the implantable device to be delivered to the desired respectivepositions on the mitral annulus 209 (called out twice). The flexibleanchor guide frame 214 may be moved into the correct orientation byadjusting a shape of an articulation mechanism 205, advancing orretracting flexible tube 201, or rotating flexible tube 201. Theflexible anchor guide frame 214 preferably has an overall shape thatenables the frame to take on a desired orientation within a cavity byconforming to the shape or being affected by the movement of anatomicalfeatures. Such a property is known as “self-locating”. Minimal insertionforce and operator guidance is typically needed to properly position theanchor guide frame 214. The flexible anchor guide frame 214 may alsohave specific features which cause the flexible anchor guide frame 214to orient correctly based on the position of an anatomical feature, suchas the mitral valve cusps or leaflets 211. An example of such a featureis alignment fin 215. Alignment fin 215 is attached rigidly to flexibleanchor guide frame 214 and shaped so that it may be deflected to aparticular orientation by an anatomical feature, such as mitral valveleaflets 211. As the flexible anchor guide frame 214 is advanced towardan anatomical feature, such as the mitral valve annulus 209, the shapeor motion of an anatomical feature, such as the mitral valve leaflets211, may cause alignment fin 215, and thus attached flexible anchorguide frame 214, to rotate or translate to a desired orientation orlocation.

The tissue anchors 207 may be inserted into the mitral annulus 209 byadvancing the push tubes 216 along various guide members (e.g., guidewires or rails) 112. The tissue anchors 207 may advance past the bend208 and embed into the mitral annulus 209. The embedded tissue anchors207 may then be released from the push tubes 216. The flexible cable 210connecting the tissue anchors 207 may then be tightened and secured toconstrict the mitral annulus 209.

FIG. 3 shows an example of a tissue anchor according to one illustratedembodiment.

The tissue anchor 301 has a helical structure with sharp tip 303, andhence is denominated as a helical tissue anchor 301. Loop 302 may beused to connect to a structure to hold the tissue anchor 301 to arelease rod. Loop 302 may also be used to attach tissue anchor 301 to acable used for cinching the annulus of a bodily orifice.

FIGS. 4A and 4B show an example of a tissue anchor according to oneillustrated embodiment.

In particular, FIG. 4A shows the tissue anchor 403 in a compressedconfiguration, while FIG. 4B shows the tissue anchor 406 in an expandedconfiguration. The tissue anchors 403, 406 include multiple barbs 408(not shown in FIG. 4A), which may be resilient. The multiple barbs 408may be compressed into constriction tube 404 as shown for tissue anchor403. Compression of barbs 408 into constriction tube 404 enables theanchor to move more readily through a catheter and also to be insertedmore readily into tissue without causing damage to the tissue.

Tissue anchor 403 may include a hole 409 that may be used to attach theanchor to a cable 401 used for cinching the annulus of a bodily orifice.Constriction tube 404 may include a slot 402 to allow tissue anchor 403to be ejected from constriction tube 404 in the case where hole 409 ismounted on a protruding flange.

Tissue anchor 406 may include a hole 407 that may be used to connect theanchor to release rod 405. Release rod 405 may be carried in a lumen ofpush tube 410. If constriction tube 404 is extended over hole 407 asshown for tissue anchor 406, release rod 405 is held captive in hole 407by the wall of constriction tube 404. If constriction tube 404 isretracted so as to not cover hole 407, as shown for tissue anchor 406,release rod 405 is not held captive in hole 407 and the tissue anchormay become disconnected from constriction tube 404 and release rod 405.

Tissue anchor 406 may be disconnected from release rod 405 and barbs 408may be uncompressed by retracting constriction tube 404 relative to therelease rod 405 and tissue anchor 406. Retracting constriction tube 404past the tips of barbs 408 causes said barbs to be released andresiliently expand. Retracting constriction tube 404 past hole 407 mayrelease tissue anchor 406.

FIGS. 5A-5E show examples of five types of tissue anchors embedded intissue.

In particular, FIG. 5A shows a helical tissue anchor 500 embedded intissue 502. The helical tissue anchor 500 includes a helical portion 501that is embedded in tissue 502 by rotating the helical tissue anchor 500about a longitudinal axis of helical portion 501. FIG. 5B shows amulti-barbed anchor 505 embedded in tissue 502. The multi-barbed tissueanchor 505 is embedded in tissue 502 by pushing the anchor into thetissue. Barbs 504 provide resistance to restrict the tissue anchor 505from being extracted. In this embodiment, multi-barbed tissue anchor 505includes an opening 503 sized to receive a guide member (not shown) orcoupling (not shown). FIG. 5C shows a tissue anchor 510 with multiplebarbs 512 (only one called out in FIG. 5C) and an integral guide line orguide wire 514 embedded in tissue 502. The barbs 512 and guide line orguide wire 514 may be secured in a shell 516 of the tissue anchor 510.For example, the barbs 512 and guide line or guide wire 514 may besecured via swaging. The guide line or guide wire 514 may take a varietyof forms, for example a metal wire such as Nitinol. FIG. 5D shows atissue anchor 520 with multiple barbs 522 (only one called out in FIG.5D) and a unitary guide line or guide wire 524 embedded in tissue 502.In contrast to the embodiment of FIG. 5C, the embodiment of FIG. 5Dforms the tissue anchor 520 and guide line or guide wire 524 from asingle piece of material, for instance a thin flexible metal wire, whichis selected from metals that are biocompatible (e.g., stainless steel,Nitinol).

FIG. 5E shows a grapple tissue anchor 530 implanted into tissue 502.Grapple tissue anchor 530 includes a plurality of elongated members 535.At least two of the elongated members (i.e., first elongated member 535a and second elongated member 535 b in this example embodiment) arepivotably coupled together by pivot member 539. Each of the elongatedmembers 535 includes a first end 536, a second end 537, an intermediateportion 538 and a respective length along the elongated member 535extending between the first end 536 and the second end 537. Each secondend 537 includes a tip 540 shaped to penetrate tissue 502. In someexample embodiments, each second end 537 includes a barb. In thisexample embodiment, each of the elongated members 535 is an arcuateelongated member. In this example embodiment, each of the elongatedmembers 535 forms a prong. Pivot member 539 allows the elongated members535 to pivot with respect to one another to space tips 540 apart fromone another into a configuration advantageous for penetrating tissue502. Upon further deployment of grapple tissue anchor 530 into tissue502, the elongated members 535 are pivoted to draw tips 540 towards eachother which causes tips 540 to travel along a path through tissue 502such that tips 540 are positioned relatively closer to one another thanduring their initial deployment into tissue 502. This allows grappletissue anchor 530 to firmly anchor itself into tissue 502. In thisexample embodiment, the plurality of elongated members 535 is physicallycoupled to a plurality of flexible lines 542 a and 542 b (collectively542). Specifically, flexible line 542 a is coupled to elongated member535 a and flexible line 542 b is physically coupled to elongated member535 b. In this example embodiment, elongated member 535 a includes anopening 544 a sized to receive flexible line 542 a and elongated member535 b includes an opening 544 b sized to receive flexible line 542 b. Insome example embodiments, a single flexible line 542 is received in anopening provided in each of the elongate members 535. In this exampleembodiment, the flexible lines 542 are guide lines. In some exampleembodiments, the flexible lines 542 and respective ones of the elongatemembers 535 are provided as a unitary structure.

FIGS. 6A and 6B show examples of tissue anchors guided by a guide memberin the form of a guide rail.

In particular, FIG. 6A shows a multi-lumen push tube 600 that may slideover a guide rail 601. Tissue anchor 602 may be temporarily attached tomulti-lumen push tube 600 by constriction tube 606 and a release rod(not shown). Sliding push tube 600 along guide rail 601 enables tissueanchor 602 to be controllably delivered to a location proximate to guiderail 601. Tissue anchor 602 may be constructed or oriented in such a waythat tissue anchor tip 607 slides along or very near to guide rail 601.Such orientation or construction enables the tip 607 to be protectedfrom obstructions in the catheter or body that may dull the tip 607.Also, such orientation or construction protects areas of tissueproximate the guide rail from inadvertent, damaging contact with thesharp tip 607 of tissue anchor 602.

FIG. 6B shows a single-lumen push tube 603 that may slide over guiderail 601. Helical tissue anchor 604 also may slide over guide rail 601and may be temporarily attached to single-lumen push tube 603 by latchmechanism 609. Latch mechanism 609 may be fastened to tissue anchor 604by a friction fitting that is released under sufficient axial force.This assembly enables tissue anchor 604 to be controllably delivered toa location proximate to guide rail 601. Tissue anchor 604 may beconstructed or oriented in such a way that tissue anchor tip 608 slidesalong or very near to guide rail 601. Such orientation or constructionenables the tip 608 of the tissue anchor 604 to be protected fromobstructions in the catheter or body that may dull tip 608. Also, suchorientation or construction protects areas of tissue proximate the guiderail 601 from inadvertent, damaging contact with the sharp tip 608 oftissue anchor 608.

While FIGS. 6A and 6B show examples of two particular types of tissueanchors being guided by a rail, it will be apparent to those skilled inthe art that many other types of tissue anchors could also be deployedwith the aid of a guide rail.

FIGS. 7A-7C illustrate a structure 701 used in a deployment of helicaltissue anchors implanted or embedded in tissue according to oneillustrated embodiment.

In particular, FIG. 7A shows a helical tissue anchor 702 partiallydeployed into tissue 708. The location where tissue anchor 702 enterstissue 708 may be determined by the position of a guide member, forinstance guide rail 704. Bend 707 in guide rail 704 may be positioned atthe approximate location where the tissue anchor 702 is to be deployedinto the tissue. Bend 707 in guide rail 704 may comprise a hinge, aflexure, or one of many other joints. Tissue anchor 702 is deployed byrotating push tube 703. The rotation of tissue anchor 702 at theposition of the bend 707 causes tissue anchor 702 to spiral off guiderail 704 and into tissue 708.

FIG. 7B shows a helical tissue anchor 705 fully deployed into tissue708, but still connected to latch mechanism 709. In the fully deployedposition, helical tissue anchor 705 may no longer wrap around guide rail704. When still connected to latch mechanism 709, the helical tissueanchor 705 may be readily retracted by counter-rotating push tube 703.

FIG. 7C shows a helical tissue anchor 706 fully deployed into tissue 708and disconnected from to latch mechanism 709. Latch mechanism 709 maybecome disconnected from tissue anchor 706 by retracting push tube 703or releasing latch mechanism 709 with the addition of another cable totrigger a release mechanism.

FIGS. 8A and 8B show a structure 801 employed in a deployment ofmulti-barbed tissue anchors in tissue according to one illustratedembodiment.

In particular, FIG. 8A shows a multi-barbed tissue anchor 805 fullyinserted into tissue 804, but still encapsulated or retained byconstriction tube 809. A location where the multi-barbed tissue anchor805 enters the tissue may be determined by the position of a guidemember, for instance guide rail 803. A bend 810 in guide rail 803 may bepositioned at the approximate location where the multi-barbed tissueanchor 805 is to be deployed into the tissue 804. The bend 810 in guiderail 803 may be constructed using a hinge, a flexure, or one of manyother methods. The multi-barbed tissue anchor 805 is deployed byadvancing push tube 802 over guide rail 803. If encapsulated or retainedby constriction tube 809, multi-barbed tissue anchor 805 may be readilyretracted by retracting push tube 802.

FIG. 8B shows a multi-barbed tissue anchor 808 fully inserted intotissue 804, but disconnected from constriction tube 811 and releasemember 806. The multi-barbed tissue anchor 808 is preferably retractedslightly before release member 806 is disconnected in order to causebarbs 807 to expand. The multi-barbed tissue anchor 808 may bedisconnected from release member 806 and barbs 807 may be expanded byretracting constriction tube 811 relative to the release member 806 andmulti-barbed tissue anchor 808. Retracting constriction tube 811 pastthe tips of barbs 807 causes the resilient barbs to be released andexpand.

FIGS. 8C through 8F show a tissue anchor 820 movably guided to tissue824 and penetrating the tissue 824 at four successive intervals of time,according to one illustrated embodiment.

In particular, FIG. 8C shows a guide member portion of an anchor guideframe 826 of a tool initially contacting the tissue 824.

The guide member portion of the anchor guide frame 826 includes an outertube 828 having two lumens 830 a, 830 b. The guide member portionincludes an engagement or locating member 832. The engagement orlocating member 832 is used to physically engage the tissue 824 suchthat the anchor guide frame 826 is at a desired location and orientationin a bodily organ. The engagement or locating member 832 is movinglycarried in one lumen 830 a of the outer tube 828. The anchor guide frame826 includes an inner or guide tube 834 movingly received in the otherlumen 830 b of the outer tube 828. The guide tube 834 functions to guidethe tissue anchor 820 to a desired location on the tissue 824. A lumen836 of the guide tube 834 carries a guide wire 838. The guide wire 838is a thin flexible wire, for example a thin Nitinol wire. The guide wire838 may include a lubricous coating or layer, such aspolytetrafluoroethylene. The guide tube 834 provides lateral support forthe guide wire 838 and retains barbs 840 (not called out in FIG. 8C) ifthe tissue anchor 820 is in a protected, contracted configuration. Abutt end of the guide tube 834 may physically engage or bear against anend or lip of the tissue anchor 820. Thus, when the guide tube 834 andguide wire are pushed, the motion is effectively delivered to the tissueanchor 820, which will advance out of the outer tube 828 along with theinner or guide tube 834. The guide tube 834 may optionally be reinforcedwith one or more wires, for instance Nitinol wires. The guide wire 838is attached to the tissue anchor 820 and functions as a guide line foran implant member (not shown in FIGS. 8C-F), as described in detailfurther below.

In particular, FIG. 8D shows the tissue anchor 820 being embedded in thetissue 824, along with a portion of the guide tube 834 and guide wire838. FIG. 8E shows the guide tube 834 partially withdrawn from aroundthe tissue anchor 820, exposing the barbs 840 of the tissue anchor 820.In going from FIG. 8D to FIG. 8E, the guide wire 838 is pushedrelatively toward the tissue 824 while the guide tube 834 is pulled ordrawn away from the tissue 824. Pushing the guide wire 838 suppliesenough force to retain the tissue anchor 820 in the tissue 824 againstany force exerted by way of withdrawal of the guide tube 834. As theguide tube 834 clears the barbs 840, the barbs 840 expand due to theresiliency of the material from which the barbs 840 are fashioned. Thetissue anchor 820 is thus secured within the tissue 824.

FIG. 8F shows the tissue anchor 820 and guide wire 838 which remainafter the portion of the anchor guide frame 826 is withdrawn. The guidetube 834 may be fully retracted into the lumen 830 b of the outer tubeor catheter 828 prior to withdrawal of the anchor guide frame 826 fromthe bodily organ. As explained in detail below, the guide wire 838 maybe used to guide an implant member (e.g., annuloplasty ring) to thetissue 824, and/or to secure the implant member to the tissue 824 at adesired position and orientation.

While illustrated with two tubes per anchoring location, someembodiments may employ three tubes per anchoring location or more. Usingonly two tubes per anchoring location advantageously increases theflexibility of the catheter(s) relative to embodiments employing morethan two tubes per anchor location. Such eases the movement of thecatheter through the bodily lumen (e.g., artery). Such may also allowthe use of catheters with smaller diameters than would otherwise benecessary to accommodate one or more additional tubes per anchoringlocation.

FIG. 9 shows an example of an anchor guide frame of a tool according toone illustrated embodiment.

An anchor guide frame 901 is used to guide tissue anchors of the implantdevice to correct insertion or anchor points or locations. The anchorguide frame 901 shown includes three guide members, for instance rails905, but said guide frame may comprise more or fewer guide members. Theanchor guide frame 901 embodiment illustrated shows all guide rails 905connected at the bottom of the guide frame 901. An anchor guide frame isnot required to have all guide members connected together, although itis often preferable to do so to create a guide frame that enables tissueanchors to be positioned relative to each other and to anatomicalfeatures. Thus, an anchor guide frame may have multiple disconnectedgroups of connected guide wires.

The anchor guide frame 901 preferably is capable of folding to enabledelivery via a catheter. Guide members (e.g., guide wires or rails) 905may be hinged at bends 902 and guide connection point 904 to enablefolding. Loop 903 facilitates folding and also acts as a spring toenable unfolding of the anchor guide frame 901.

Guide members 905 may be formed to have respective bends 906 when noexternal forces are being applied. When guide members 905 are carried ina catheter with an articulation mechanism shaped into a curve as shownin FIG. 2, the forces exerted on the guide member by the catheter andarticulation mechanism will cause bend 906 to align with the curve inthe articulation mechanism. Such alignment causes anchor guide frame 901to rotate to a desired position relative to the catheter orientation.Bend 906 may also be formed to assist in curving the articulationmechanism in a particular way.

An anchor guide frame may also contain additional features which useanatomical features or movement to assist in orientation of said anchorguide mechanism or guide frame 901. An example of such a feature is analignment fin 907. Alignment fin 907 is attached rigidly to flexibleanchor guide frame 901 and shaped so that the alignment fin 907 may bedeflected by an anatomical feature, such as mitral valve leaflets, to aparticular orientation. As the flexible anchor guide frame 901 isadvanced toward an anatomical feature, such as the mitral valve annulus,the shape or motion of an anatomical feature, such as the mitral valveleaflets, may cause alignment fin 907, and thus flexible anchor guideframe 901, to rotate to a desired orientation.

FIG. 10 shows an anchor guide frame folded for delivery inside acatheter according to one illustrated embodiment.

An anchor guide frame including guide members (e.g., guide wires orrails) 1004 may be folded inside a catheter sheath 1001. Hinges 1006 andloop 1007 enhance folding of the anchor guide mechanism. In theembodiment illustrated, tissue anchors 1003 fit between the guidemembers 1004 in the folded configuration. Protective anchor cap 1005holds and covers the sharp tips of tissue anchors 1003 and may ensurethat the tips do not catch or embed on the sides of catheter sheath1001. Protective anchor cap 1005 may be held in place by control wire1002.

FIG. 11 shows an anchor guide frame in an expanded configurationaccording to one illustrated embodiment.

An anchor guide frame 1112 may self expand after exiting catheter sheath1111. In particular, the anchor guide frame 1112 may be formed of aresilient material or a shape memory material such as Nitinol. Loop 1106may be formed to cause the anchor guide frame 1112 to expand. Hinges1105 facilitate separation of guide members 1104 by about 20 mm to 45mm. In the illustrated embodiment, tissue anchors 1109 are held withinthe volume encompassed by anchor guide frame 1112 which ensures thetissue anchors 1109 do not accidentally impinge tissue. Also, the tipsof the tissue anchors are held captive within protective anchor cap1110. The tips of the tissue anchors may be released by advancingcontrol wire 1103 and thereby also advancing anchor cap 1110. The tipsof the tissue anchors are no longer held captive if anchor cap 1110 isadvanced sufficiently to a point past the tips of the tissue anchors. Asguide members 1104 curve away from anchor cap 1110, advancing tissueanchors 1109 causes the tips of the tissue anchors to move away from andavoid anchor cap 1110.

Articulation mechanism 1107 (e.g., articulation joints) of the tool isshown in a curved configuration or state. Articulation mechanism 1107may be curved using wires (not shown) that are carried on opposing sidesrelative to a longitudinal axis of the articulation mechanism and fixedto the distal end of the articulation mechanism 1107. Tensioning onewire causes the articulation mechanism 1107 to arc in the direction ofthe side of the articulation mechanism on which the tensioned wire iscarried in. For some situations, it is desirable to cause gaps betweenarticulation links or articulation joints to open at different rates.For example, when inserting articulation mechanism 1107 into the leftatrium, it may be preferable to cause the distal links, such asarticulation link or joint 1113 and articulation link or joint 1114, toseparate or bend prior to or more than the proximal articulation linksor joints, such as articulation link or joint 1115 and articulation linkor joint 1116. One embodiment to enable such an attribute is to insertsprings, as indicated by 1108 and 1102, with varying spring constant kbetween the links or articulation joints. To cause the distal end ofarticulation mechanism 1107 to bend first, the distal links should beforced apart by springs with a higher spring constant than the springsbetween the proximal links. Another embodiment for enabling unequalseparation of articulation links or joints is to control the shape ofthe guide members 1104 that are routed through the articulationmechanism 1107. The guide members should have a preformed bend with adecreasing radius of curvature in the area from proximal articulationlink or joint 1115 to distal articulation link or joint 1114.

FIG. 12 shows a configuration of tissue anchors and push tubes at adistal tip of a medical device system according to one illustratedembodiment. For clarity, FIG. 12 omits guide members and anchor guideframe that would typically be located at the distal tip of the medicaldevice system.

An articulation mechanism 1204 may include multiple lumens 1208 throughwhich push tubes 1202 are carried. In this particular embodiment, threelumens 1208 (two called out) are employed, but other embodiments maycomprise more or less. Push tubes 1202 may also include multiple lumens.In this particular embodiment, each push tube 1202 has a lumen 1201 inwhich a guide member (e.g., guide wire or rail) (not shown) may becarried and a second

-   -   lumen that carries a release member (e.g., rod or wire) (not        shown) which is connected to the tissue anchors 1209.        Constriction tubes 1205 may be mated into or onto the distal end        of the second lumen. All tissue anchors may be connected by a        flexible cable 1207. The flexible cable 1207 may also be carried        within a separate lumen within the articulation mechanism 1204.        Lumens 1203 are used to carry lines 1206 that control the        curvature of the articulation mechanism 1204.

FIG. 13 shows a cross section of a heart with an anchor guide frameaccording to one illustrated embodiment positioned within a left atriumof the heart.

An anchor guide frame 1303 is shown self-located on a mitral annulus1304 within the left atrium. The tissue anchor deployment sites 1301 arepreferably located on the mitral annulus and coincident with bends inthe guide members (e.g., guide wires or rails) 1302. While FIG. 13 showsthree guide members 1302 and tissue deployment sites 1301 forsimplicity, in many cases more deployment sites and guide members aredesirable. In such cases, it is a simple matter to add additional guidemembers and anchor deployment sites to the illustrated embodiment.

An alignment fin 1305 may fit between mitral valve leaflets 1306. Themovement and anatomical structure of the mitral valve leaflets 1306exert force on alignment fin 1305 and assist in orienting the anchorguide frame 1303 correctly.

FIG. 14 shows a cross section of a heart with an installed assemblycapable of constricting a mitral valve annulus according to oneillustrated embodiment.

Tissue anchors 1401, 1402, and 1403 are shown fully deployed on themitral annulus 1406. Tissue anchors 1401-1403 may be connected by aflexible cable 1405. Other mechanisms for connecting tissue anchors1401, 1402, 1403 are possible. For example, rigid members, preferablywith adjustable length (e.g., turn-buckles), may be used to connect thetissue anchors 1401-1403. Flexible cable 1405 may slide through holes onthe tissue anchors 1401, 1402, 1403.

Flexible cable 1405 may pass through a hollow spreader bar 1404. Hollowspreader bar 1404 provides support to keep tissue anchors 1401 and 1403from moving closer together when flexible cable 1405 is shortened. Suchsupport reduces undesired forces being applied to an aortic valve 1407of the heart.

Reducing a distance between pairs of the tissue anchors 1401, 1402 and1402, 1403 causes an anterior-posterior (A-P) annular dimension of themitral valve to reduce and improves leaflet coaptation. Several methodsmay be used to reduce the distance between two or more pairs of tissueanchors 1401, 1402 and 1402, 1403. A first method is to shorten thecable during the installation procedure by routing the flexible cable1405 through fastener 1408, pulling the cable manually to be as tight asdesired and crimping fastener 1408. Fastener 1408 may also beconstructed using a one way clutch so that the flexible cable 1405 canonly be pulled through in one direction, in which case crimping is notrequired. A second method of reducing tissue anchor separation (i.e.,distance between two successive tissue anchors) is to include shorteningactuator 1409 between two tissue anchors. In the case where shorteningactuator 1409 is included, flexible cable 1405 is split and attached toeither end of the shortening actuator. One embodiment of shorteningactuator 1409 contains an element that is capable of changing length inresponse to a stimulus such as changes in an external magnetic field orheating induced by a changing magnetic field. The element capable ofchanging lengths may be made of a highly magnetostrictive alloy such asTerfenol-D or from a Shape Memory Alloy (SMA) such as specially treatedNitinol. Embodiments of such actuators are described in U.S. patentapplication Ser. No. 11/902,199. The element capable of changing lengthsmay be made of a spring under tension (e.g., in an extendedconfiguration) encapsulated in a retainer material that changes state inresponse to a stimulus (e.g., melts under low heat and solidifies atbody temperature—such as a thermoplastic polymer). Current induced in aloop by an external magnetic field may be channeled through the spring.The current may heat the spring which will cause the polymer to softenand the spring length to contract to an unextended configuration. Thecontraction of the spring can be used to reduce the separation of thetissue anchors. Embodiments of such actuators are described in U.S.patent application Ser. No. 11/905,771.

A closed, electrically conducting loop is required if shorteningactuator 1409 is to be responsive to heating or energy induced by achanging magnetic field. Such a loop may be achieved by using anelectrically conductive material for flexible cable 1405 and ensuring anelectrical contact between both ends of flexible cable 1405 that areconnected to shortening actuator 1409.

FIGS. 15A and 15B show a tool and fastener used to tighten and secure acable according to one illustrated embodiment.

Fastener 1507 may be used to tighten or secure cables being used toconstrict a bodily orifice. Typically prior to attachment of fastener1507, tissue anchors have been implanted or placed in the tissue, and aflexible cable has been connected to the tissue anchors. Cable end 1504and cable end 1503 are typically carried in catheter sheath 1505 androuted outside the body. Cable end 1504 and cable end 1503 may be thetwo ends of one flexible cable. The portion of the cable not shown loopsaround the orifice to be constricted and is attached to the implantedtissue anchors used to secure the cable to the orifice.

Cable end 1504 may be fed into hole 1511 and locked by ferrule 1510while fastener 1507 is still outside the body. Cable end 1503 may berouted through taper lock 1509 while fastener 1507 is still outside thebody.

Fastener 1507 may be attached to fastener positioning tube 1506. Cableend 1503 may be inserted through slot 1502 and into fastener positioningtube 1506. Fastener 1507 and fastener positioning tube 1506 may beinserted into catheter sheath 1505 and advanced until fastener 1507 isproximate an annulus of the orifice to be constricted. Cable end 1503may be pulled in a direction away from fastener 1507, causing the cableto pull through taper lock 1509 and constrict the orifice. While thecable is being tightened and secured, fastener 1507 may be held byfastener positioning tube 1506. Taper lock 1509 restricts cable end 1503from being pulled out the right side (as illustrated in FIGS. 15A, 15B)of fastener 1507. Taper lock 1509 may have teeth 1515 to grip cable end1503. Taper lock 1509 may have a longitudinal slot to enable compressionof taper lock 1509 and constriction around cable end 1503. Spring 1508may force taper lock 1509 into a conical hole 1514, causing the taperlock 1509 to tighten around cable end 1503.

When the orifice has been sufficiently constricted, cable end 1503 maybe severed using cable cutting tube 1501. Cable cutting tube 1501includes a sharpened end 1516. In particular, FIG. 15A shows cablecutting tube 1501 in a retracted position. The cable cutting tube mayslide inside of fastener positioning tube 1506. FIG. 15B shows cablecutting tube 1512 in the cable cutting position, physically engaging thecable 1513. Cable cutting tube 1512 may sever cable end 1513 by forcingcable end 1513 against the end of slot 1516. The cable end may besevered in other ways, including using a hot tip to melt through thecable.

FIGS. 16A and 16B show a catheter with grooves, or side slots, and amechanism for securing cables or wires in said side slots according toone illustrated embodiment.

In particular, FIG. 16A shows catheter 1604 with cables 1601 held withinlongitudinal groove 1603 on the inner surface of the tube wall by tube1602. The longitudinal groove 1603 has a cross sectional shape thatenables tube 1602 to be held captive. FIG. 16A shows a circular groove(i.e., arcuate cross-section), but other shapes may be used. Tube 1602carries cables 1601. Tube 1602 could also carry wires or tubes. Whentube 1602 is removed by pulling it out the end, as shown in FIG. 16B bycatheter 1607, cables 1605 are free to move into the central area of thetube. Tube 1602 can be reinserted over cables 1605 to again constrainthem in groove 1603.

Although FIGS. 16A and 16B show catheter 1604 and catheter 1607 withonly one groove 1603, it is possible to have many such grooves in acatheter and to secure a plurality of wires and tubes in said grooves.One of the reasons for securing cables or wires in grooves, or sideslots, is to eliminate tangling of cables or wires during medicalprocedures.

FIG. 17 shows a mechanism for holding a tissue anchor captive accordingto one illustrated embodiment.

Tissue anchor 1703 may be held captive in constriction tube 1706 of thetool by release member 1704. Constriction tube 1706 may be inserted andsecured to a distal end of one lumen of push tube 1701. Constrictiontube 1706 may be held captive in the lumen by one or more ribs 1705.

Tissue anchor 1703 may be released from constriction tube 1706 byretracting push tube 1701 and constriction tube 1706 relative to releasemember 1704. As the distal end of constriction tube 1706 clears hole1707, tip of release member 1708 will pop out of hole 1707 and tissueanchor 1703 will no longer be held captive.

Lumen 1702 of push tube 1701 may be used to slide over a guide member.

FIGS. 18A and 18B show mechanisms for restricting a tissue anchor fromrelease until the anchor is fully embedded in tissue according to oneillustrated embodiment

An additional benefit is provided if the tool to implant the implantabledevice for constricting a bodily orifice does not release tissue anchorsof the implantable device until the tissue anchors are fully embedded inthe tissue. It is possible to achieve this benefit by adding anadditional latch 1806, 1810 to the tool.

In particular, FIG. 18A shows a tissue anchor 1802 prior to deployment.The tissue anchor 1802 may not be released from constriction tube 1805by retracting push tube 1803 and constriction tube 1805 relative torelease member 1804 because latch 1806 in an engaged or locked positionextends into a notch 1801. Latch 1806 is coupled to lever 1807 in thisillustrated embodiment.

FIG. 18B shows the tissue anchor 1808 fully deployed into tissue 1812.As tissue anchor 1808 was deployed into tissue 1812, the surface oftissue 1812 causes lever 1811 to bend. When lever 1811 is bent, latch1810 clears notch 1813. Once latch 1810 clears notch 1813, tissue anchor1808 may be released from constriction tube 1809.

FIGS. 19A-19D show an implant member 1900, according to one illustratedembodiment. In particular, FIGS. 19A and 19B show the implant member ina first configuration that is representative of one of a deliveryconfiguration, an unanchored configuration or an untensionedconfiguration, while FIGS. 19C and 19D show the implant member in asecond configuration that is representative of one of an implantableconfiguration, a deployed configuration, an anchored configuration or atensioned configuration. This implant member 1900 may be particularlysuitable for use with the tissue anchors, anchoring guiding frame andtechniques of FIGS. 5C, 5D, and FIGS. 8C-8F.

The implant member 1900 may be used to reshape, reconfigure and/orreinforce an orifice in bodily tissue. For example, the implant member1900 may be used to reshape, reconfigure and/or reinforce a valve, forinstance a natural valve or an artificial valve. The valve may, forexample, take the form of a mitral, tricuspid, pulmonary and/or aorticvalve of the heart. Alternatively, the valve may take the form ofanother valve in another organ of the body.

The implant member 1900 has a plurality of arcuate segments 1902 a-1902c (collectively 1902). While three segments 1902 are illustrated, theimplant member 1900 may include additional segments. The total number ofsegments 1902 may be based on the size of the valve that the implantmember 1900 will be used with. The total number of segments 1902 mayadditionally or alternatively be based on a largest lateral dimensionthat may be accommodated by a given or desired catheter (i.e., diameterof catheter lumen). For instance, employing a greater number of segments1902 means that each segment may have a smaller height 1922, while stillachieving a desired lateral dimension or height of the overall implantmember 1900 when in the implanted configuration.

The segments 1902 are physically coupled to one another, and in at leastsome configurations are articulated for movement with respect to oneanother, for example pivotal movement. The implant member 1900 includesa number of hinges 1904 a, 1904 b (collectively 1904 pivotally couplingneighboring ones of the segments 1902. Each hinge 1904 may include ahinge pin 1906 a, 1906 b (collectively 1906) received via through holes1908 a, 1908 b (collectively 1908) (not called out in FIG. 19A) in thesegments 1902. The hinge pin 1906 should be fixedly received in thethroughhole 1908 to ensure that the hinge pin 1906 does not becomedislodged after implantation. The hinge pin 1906 may be swaged in thethroughhole 1908, and may additionally or alternatively be fixed usingother mechanisms. The locations of the hinge pins 1906 of the hinges1904 may be offset from a longitudinal centerline (i.e., the arc thatpasses longitudinally through the geometric center between thelongitudinal arcuate edges) of the respective one of the arcuatesegments 1902. Such may avoid having to remove material on an outsideedge to allow the segments 1902 to pivot. Alternatively, the hinge pins1906 may lie along the longitudinal centerline.

The segments 1902 include stops 1909 a-1909 d (collectively 1909)proximate the hinges 1904. The stops 1909 on neighboring ones of thesegments 1902 cooperatively interact by engaging one another to preventthe segments 1902 from being pivoted past a defined angle with respectto one another. The stops thus serve to lock the segments 1902 fromfurther articulation in one direction, from the delivery configurationto the implanted configuration. While illustrated as simplecomplementary engagement surfaces, the stops may take other forms. Forexample, stops may take the form a detent or other lock structure. Stops1909 may lock the segments 1902 from movement in two, opposeddirections. Stops 1909 may also provide torsional stiffness to thehinges 1904.

In some example embodiments, a portion of an implant member having avariable bending stiffness in at least one dimensional plane isemployed. In this illustrated embodiment, implant member 1900 isconfigured to be bendable between a first configuration in which implantmember 1900 has a generally elongated shape and a second configurationin which implant member 1900 has an arcuate shape. Stops 1909 allowportions of the implant member 1900 coupled by hinges 1904 to have avariable bending stiffness in at least one dimensional plane. Hinges1904 allow implant member 1900 to bend via the articulation of segments1902 in a plane when implant member 1900 is in its first configuration.Stops 1909 restrain further articulation between segments 1902 whenimplant member 1900 is in the second configuration and any furtherbending is dependent on any additional flexing of segments 1902. In thisregard, the implant member 1900 has a reduced bending stiffness in theat least one dimensional plane when the implant member 1900 is in thefirst configuration and an increased bending stiffness in the onedimensional plane when the implant member 1900 is in the secondconfiguration. Variable bending stiffness characteristics can beachieved in other ways by other example embodiments. The implant member1900 includes a number of guide line receivers 1910 a-1910 c(collectively 1910). The guide line receivers 1910 may be formed asholes or apertures and are sized to receive a guide line such as a guidewire (not shown in FIGS. 19A-19D) to allow the implant member 1900 toride on or otherwise be guided or advanced along the guide line. Theguide line may, for example, take the form of the guide wire of FIGS.5C, 5D and FIGS. 8C-8F. In various embodiments, the guide line receivers1910 allow implant member 1900 to ride on, or otherwise be guided oradvanced along a guide line that is received or coupled to a tissueanchor that is embedded into tissue. The guide line receivers 1910 a,1910 c are located proximate a first end 1912 a, a second end 1912 b,respectively. The guide line receiver 1910 b is between the first andsecond ends 1912 a, 1912 b. In particular, each of the segments 1902 mayhave at least one of the guide line receivers 1910. While illustrated asbeing approximately midway between the first and second ends 1912 a,1912 b, the guide line receiver 1910 b between the first and second ends1912 a, 1912 b may be offset to one side or the other of a center line(perpendicular bisector 1924) of the implant member 1900, along alongitudinal axis thereof. The implant member 1900 may includeadditional guide line receivers (not shown). For instance, all or someof one or more additional segments (not shown) may have guide linereceivers. Additionally, or alternatively, one segment 1902 may havemore than one guide line receiver 1910. One or more of the segments 1902may include relief 1911 (only one called out in FIG. 19B) proximate theguide line receiver 1910. The relief 1911 may accommodate a guide linesuch as a wire or suture.

As illustrated in FIGS. 19A and 19B, the segments 1902 of the implantmember 1900 may be moved with respect to one another, into a firstconfiguration, which in this illustrated embodiment is representative ofa delivery configuration or unanchored configuration. In the delivery orunanchored configuration, the implant member 1900 is sized anddimensioned to be deliverable via a catheter. In the deliveryconfiguration, the implant member 1900 may have an elongated, scallop orserpentine profile, as best illustrated in FIG. 19B. A maximumlongitudinal dimension in the delivery or unanchored configuration isrelatively long as compared to the maximum longitudinal dimension in theimplanted or anchored configuration. Thus, a maximum lateral dimensionof the implant member 1900 (i.e., maximum dimension measuredperpendicularly to a longitudinal axis extending between the first andsecond ends 1912 a, 1912 b), is minimized. The maximum lateral dimensionin the delivery or unanchored configurations is relatively short orsmall as compared to the maximum lateral dimension in a secondconfiguration, which in this illustrated embodiment is representative ofan implantable or deployed or anchored configuration. As illustrated inFIG. 19B, the maximum lateral dimension may, for example, beapproximately equal to a height 1922 of the arch formed by the one ofthe arcuate segments 1902 (i.e., 1902 b in this illustrated embodiment),as measured by a perpendicular bisector 1924 that extends from a chordline 1926 passing tangent to portions of an inner surface 1928 (calledout twice in FIG. 19B) of one or more of the arcuate segments 1902, towhere the perpendicular bisector 1924 intersects an outer surface 1930of the arcuate segment 1902 when the plurality of arcuate segments arepositioned in the delivery or unanchored configuration. Thus, theimplant member 1900 may be accommodated by a catheter. Catheters aretypically long, but have relatively narrow diameters. Thus, cathetershave relatively unlimited longitudinal capacity as compared to lateralor radial capacity.

As illustrated in FIGS. 19C and 19D, the segments 1902 of the implantmember 1900 may be moved with respect to one another into the secondconfiguration representative of an implantable or deployed or anchoredconfiguration. In the second configuration, the implant member 1900 hasan arcuate or annular shape or profile. The arcuate or annular shape issized and dimensioned to encompass at least part of an orifice. Forexample, the arcuate or annular shape may be sized and dimensioned tooverlie part of an annulus of a mitral valve of a heart. In the secondconfiguration, the dimensions of the implant member 1900 are too largeto be accommodated by a typical catheter. In particular, a lateraldimension or height of the implant member is too large to be received bya lumen of the catheter.

As described in detail below, forces or tension may be applied to theimplant member 1900 at the guide line receivers 1910, for instance viaembedded tissue anchors and/or wires and/or sutures. Such may tensionthe implant member 1900 into the second configuration (FIGS. 19C and19D), while the stops 1909 prevent the segments 1902 of implant member1900 from articulating past the implanted configuration. Such results inthe implant member 1900 having a generally rigid structure in the secondconfiguration.

FIG. 20A-20D show an implant member 2000, according to one illustratedembodiment. In particular, FIGS. 20A and 20B show the implant member2000 in a first configuration representative of a delivery configurationor an unanchored configuration, while FIGS. 20C and 20D show the implantmember 2000 in a second configuration representative of a deployedconfiguration or an implantable configuration or an anchoredconfiguration. This implant member 2000 may be particularly suitable foruse with the tissue anchors, anchoring guiding frame and techniques ofFIGS. 5C, 5D, and FIGS. 8C-8F, by way of non-limiting example.

The implant member 2000 may be used to reshape, reconfigure and/orreinforce an orifice in bodily tissue. For example, the implant member2000 may be used to reshape, reconfigure and/or reinforce a valve, forinstance a natural valve or an artificial valve. The valve may, forexample take the form of a mitral, tricuspid, pulmonary and/or aorticvalve of the heart. Alternatively, the valve may take the form ofanother valve in another organ of the body.

The implant member 2000 has a plurality of arcuate segments 2002 a-2002h (collectively 2002). While eight segments 2002 are illustrated, theimplant member 2000 may include fewer or a greater number of segments.The total number of segments 2002 may be based on the size of the valvethat the implant member 2000 will be used with. The total number ofsegments 2002 may additionally or alternatively be based on a largestlateral dimension that may be accommodated by a given or desiredcatheter (i.e., diameter of catheter lumen). For instance, employing agreater number of segments 2002 means that the implant member 2000 mayhave a smaller height in the first configuration, while still achievinga desired lateral dimension or height of the overall implant member 2000when in the second configuration.

The segments 2002 are physically coupled to one another, and in at leastsome configurations are articulated for movement with respect to oneanother, for example pivotal movement. The implant member 2000 includesa number of flexure joints 2004 a-2004 g (collectively 2004) pivotallycoupling neighboring ones of the segments 2002. Each flexure joint 2004may be defined by a recess 2006 (only one called out in FIG. 20C)defined in the implant member 2000. Thus, in contrast to the implantmember 1900 (FIGS. 19A-19D), the implant member 2000 may be a unitarystructure formed from a single piece of material. The recesses 2006 areillustrated as being on an inner radius, diameter or surface 2019 of theimplant member 2000. Alternatively, recesses may be formed on an outerradius, diameter or outer peripheral surface 2020 of the implant member,diametrically opposed to the recesses 2006 illustrated in FIGS. 20A-20D.

The recesses 2006 may be defined or formed via machining operations, forinstance drilling, milling, laser cutting, water jetting, etc. Inparticular the recesses 2006 may have an entrance 2008 (only one calledout in FIG. 20C) at an inner peripheral surface 2019 of the implantmember 2000, and may have an enlarged portion 2009 (only one called outin FIG. 20C) spaced inwardly of the entrance 2008. The recesses 2006 mayhave rounded corners which may alleviate stress and/or possible crackformation. Such may also prevent snagging or tearing of bodily tissue.

The implant member 2000 may employ the resiliency of the material fromwhich the implant member 2000 is formed to limit the bending or travelof the segments 2002. Alternatively, the implant member 2000 may includestops proximate the flexure joints 2004. The stops on neighboring onesof the segment 2002 would cooperatively interact by engaging one anotherto prevent the segments 2002 from being pivoted past a defined anglewith respect to one another. Accordingly, in various exampleembodiments, a portion of implant member 2000 has a variable stiffnessin at least one dimensional plane. In a manner similar to otherdescribed embodiments, the use of stops can allow implant member 2000 tohave a reduced bending stiffness when implant member 2000 is in itsfirst configuration and an increased bending stiffness when implantmember 2000 is in its second configuration. In this example embodiment,a portion of implant member 2000 has a substantially equal bendingstiffness in each of a plurality of directions in at least onedimensional plane when implant member 2000 is in its first configurationwhile the portion of implant member 2000 has a substantially unequalbending stiffness in each of the plurality of directions in the at leastone dimensional plane when implant member 2000 is in its secondconfiguration. In this example embodiment, the stops provide the unequalbending stiffness in each of the plurality of directions in the at leastone dimensional plane when implant member 2000 is in its secondconfiguration.

The implant member 2000 includes a number of guide line receivers 2010a-2010 c (collectively 2010). The guide line receivers 2010 are formedas holes or apertures and are sized to receive a guide line or wire (notshown in FIGS. 20A-20D) to allow the implant member 2000 to ride on orotherwise be guided or advanced along the guide line. The guide linereceivers 2010 are located proximate a first end 2012 a, a second end2012 b and a location between the first and second ends 2012 a, 2012 b.In particular, only some of the segments 2002 may have one of the guideline receivers 2010. While illustrated as being approximately midwaybetween the first and second ends 2012 a, 2012 b, the guide linereceiver 2010 b between the first and second ends 2012 a, 2012 b may beoffset to one side or the other of a center line (perpendicular bisector2024) of the implant member 2000, along a longitudinal axis thereof. Theimplant member 2000 may include additional guide line receivers (notshown). For instance, all or some of one or more additional segments(not shown) may have guide line receivers. Additionally, oralternatively, one segment 2002 may have more than one guide receiver2010. Similar to previously described embodiments, each of one or moreof the segments 2002 may include a relief (not shown) proximate theguide receiver 2010. Each of these reliefs may accommodate a guide linesuch as a guide wire or suture.

As illustrated in FIGS. 20A and 20B, the segments 2002 of the implantmember 2000 may be moved with respect to one another, into a firstconfiguration representative of a delivery or unanchored configuration.In the first configuration, the implant member 2000 is sized anddimensioned to be deliverable via a catheter. In the firstconfiguration, the implant member 2000 may have an elongated crenulatedprofile, as best illustrated in FIG. 20B. A maximum longitudinaldimension in the first configuration is relatively long as compared tothe maximum longitudinal dimension in a second configuration that isrepresentative of an implantable, deployed or anchored configuration.Thus, a maximum lateral dimension of the implant member 2000 (i.e.,maximum dimension measured perpendicularly to a longitudinal axisextending between the first and second ends 2012 a, 2012 b), is reduced.The maximum lateral dimension in the first configuration is relativelyshort or small as compared to the maximum lateral dimension in thesecond configuration. As illustrated in FIG. 20B, the maximum lateraldimension may, for example, be approximately equal to a height 2022 ofthe arch formed by the implant member 2000, as measured by aperpendicular bisector 2024 that extends from a chord line 2026 passingtangent to portions 2028 of an inner surface located at the first andsecond ends 2012 a, 2012 b, to where the perpendicular bisector 2024intersects an outer surface 2020 of the implant member 2000. Thus, theimplant member 2000 may be accommodated by a catheter, which cathetersare typically long but which have relatively narrow diameters.

As illustrated in FIGS. 20C and 20D, the segments 2002 of the implantmember 2000 may be moved with respect to one another into a secondconfiguration representative of an implantable, deployed or anchoredconfiguration. In the second configuration, the implant member 2000 hasan arcuate, annular or C-shape or profile. The arcuate, annular orC-shape is sized and dimension to encompass at least part of an orifice.In the second configuration, the dimensions of the implant member 2000are too large to be accommodated by a typical catheter sheath. Inparticular, a lateral dimension or height of the implant member is toolarge to be received by a lumen of the catheter.

As described in detail below, forces or tension may be applied to theimplant member 2000 at the guide line receivers 2010, for instance viatissue anchors and/or guide lines, guide wires and/or sutures. Such maytension the implant member 2000 into the second configuration (FIGS. 20Cand 20D).

FIG. 20E shows an implant cross member 2050, according to oneillustrated embodiment. The implant cross member 2050 may have two ormore guide line receivers 2052, to receive guide lines such as guidewires (not shown in FIG. 20E). The guide line receivers 2052 may beproximate opposite ends of the implant cross member 2050. Thus, theimplant cross member 2050 may ride or otherwise advance along the guidelines or guide wires toward tissue anchors embedded in tissue. Theimplant cross member 2050 can be anchored across the ends of arms of animplant member such as implant member 1900 (FIGS. 19A-19D), or implantmember 2000 (FIGS. 20A-20D) to form a generally D-shape profile with theimplant member. The implant cross member 2050 may take the form of anelongated generally rigid structure or an elongated cable or wire, whichis generally rigid once anchored. Such may result in a more rigidstructure than the structures having generally C-shaped profiles. Theimplant cross member 2050 may optionally include couplers (not shown) tocouple to complementary couplers on the implant member 1900, 2000.

In contrast to other valve reformation structures, at least some of theimplant members described herein such as implant members 1900 (FIGS.19A-19D), 2000 (FIGS. 20A-20D), do not need to have a cable passingthrough all of the segments as the sole means of coupling the varioussegments together. In contrast to other valve reformation structures,implant members such as implant members 1900 (FIGS. 19A-19D), 2000(FIGS. 20A-20D) do not need to be positioned on tissue surrounding avalve, and then secured to the surrounding tissue and finally cinchedtogether to alter the shape of the valve. Rather, in variousembodiments, implant members such as implant members 1900, 2000 aresecured to tissue anchors (i.e., FIG. 3, FIGS. 4A-4B, FIGS. 5A-5D, FIGS.6A-6B, FIGS. 7A-7C and FIGS. 8A-8D, by way of non-limiting example) thathave been previously embedded or previously anchored into the tissuesurrounding the orifice proximate at least three locations. It is notedthat in some example embodiments, each tissue anchor is individuallyembedded into tissue, while in other example embodiments, the tissueanchors are embedded into the tissue as a group. In the previouslydescribed example embodiments, guide lines that are received or coupledto the embedded tissue are received by guide line receivers 1910, 2010provided by respective ones of implant members 1900, 2000 to provide aphysical path for implant member 1900, 2000 to travel to the embeddedtissue anchors. As the implant member 1900, 2000 travels towards theembedded tissue anchors, each of the guidelines is configured to receivea tensile force sufficient to apply force to bend or position implantmember 1900, 2000 into its deployed or implantable configuration (i.e.,the second configuration). In various example embodiments, at least someof the guide lines impart force to the implant member 1900, 2000 as itmoves along the physical path to the embedded tissue anchors.

In various example embodiments, the implant member 1900, 2000 isappropriately sized and dimensioned so that the tensile force applied toeach of the guide lines is sufficient to cause a portion of the tissueinto which a respective tissue anchor is embedded to move towards theimplant member 1900, 2000 as the implant member 1900, 2000 is positionedinto its second configuration. In various example embodiments, thesegments 1902, 2002 of respective ones of the implant member 1900, 2000in the second configuration enclose at least partially an area that issmaller than an area of an annulus of an orifice (e.g., a mitral valve)prior to a physical coupling between the implant member 1900, 2000 andthe tissue. In various example embodiments, a circumference defined by acircle passing through at least three locations of the guide linereceivers 1910, 2010 on a respective one of the implant member 1900,2000 in the second configuration is smaller than a circumference of anannulus of the tissue orifice or valve prior to a physical couplingbetween the implant member 1900, 2000 and the embedded tissue anchors.In various example embodiments, a circumference defined by a circlepassing through at least three locations of the guide line receivers1910, 2010 on a respective one of the implant member 1900, 2000 in thesecond configuration is smaller than a circumference defined by a circlepassing through at least three locations of the embedded tissue anchorsprior to a physical coupling between the implant member 1900, 2000 andthe embedded tissue anchors.

It is noted that the force applied by the anchoring maintains theimplant member 1900, 2000 under tension in the desired implantableconfiguration when the implant member 1900, 2000 is finally secured tothe tissue. Advantageously, implant member 1900, 2000 is positionablebetween a first configuration in which respective ones of segments 1902,2002 are articulable with respect to one another such that the implantmember 1900, 2000 is manipulable to a size and dimension to be deliveredvia a catheter and a second configuration in which the segments 1902,2002 form a structure sufficiently rigid to affect a shape of a tissuevalve or orifice in a desired manner. In this regard, each of theimplant member 1900, 2000 has a reduced bending stiffness in at leastone dimensional plane in the first configuration to allow it to bedeliverable via a catheter and an increased bending stiffness in the atleast one dimensional plane sufficient to form a structure sufficientlyrigid to affect the shape of a tissue orifice or valve in a desiredmanner. In various example embodiments, the guide lines and embeddedtissue anchors apply tension to the implant member 1900, 2000 in thesecond configuration that is sufficient to restrain disengagement of arespective one of a coupled segment 1902, 2002 with a stop associatedwith the coupled segment. In various example embodiments, the guidelines and embedded tissue anchors apply tension to the implant member1900, 2000 in the second configuration that is sufficient to flex atleast one of a respective segment 1902, 2002 while the segment engageswith an associated stop. The applied tension provided to the implantedimplant member 1900 in these example embodiments may reduce wear on thecomponents of the associated hinges 1904 as the implanted implant member1900 is subsequently repeatedly stressed by the recipient's cardiaccycle which can be in the millions of cycles. The applied tensionprovided to the implanted implant member 2000 in these exampleembodiments may reduce fatigue effects as the implanted implant member2000 is subsequently repeatedly stressed by the recipient's cardiaccycle. While some of the described embodiments may employ a cablebetween end segments of the articulated structure as an implant crossmember, adjacent pairs of the segments are coupled together viarespective hinges rather than a cable.

The implant member 1900, 2000 may, for example, have a length (e.g.,measured from guide receiver 1910 a to 1910 b) of from approximately 24mm to approximately 38 mm, inclusive. Implant members 1900, 2000 may beavailable in a variety of lengths, for instance in 2 mm increments, toaccommodate various valve sizes. The implant members 1900, 2000 may havea thickness of approximate 2 mm, although other thickness may beemployed. The width of the segments of the implant members 1900, 2000may, for example, be approximately 2 mm, although other widths may beemployed. The implant members 1900, 2000 may, for example, have a heightthat is between approximately 30% and approximately 50% of thelongitudinal length. The implant members 1900, 2000 may, for example,have a height that is between approximately 60% and approximately 65% ofthe longitudinal length, for example 63% of the longitudinal length.Such ratio may provide sufficient force to approximate theanterior-posterior dimension of a mitral valve.

In some embodiments, the implant member 1900, 2000 may, for example,have an arcuate, annular or C-shape. The implant member 1900, 2000 maybe sized and dimension to encompass over a third or over half (i.e.,substantially) of the orifice. For example, the arcuate, annular orC-shape may be sized and dimensioned to overlie part of an annulus of amitral valve of a heart, surrounding approximately half the mitralvalve. Such may advantageously allow the anterior-posterior dimension ofthe mitral valve to be modified (e.g., reduced). Implant members such asimplant members 1900, 2000 may be formed from or comprise a variety ofmaterials. The materials may include a biocompatible material which doesnot react in or with the tissue or bodily fluids. For example, theimplant members 1900, 2000 and/or implant cross member 2050 may beformed of metals such as Nitinol, stainless steel, platinum, iridium,titanium, or polymers such as polytetrafluoroethylene (PTFE) orsilicone. Also for example, the implant members 1900, 2000 and/orimplant cross member 2050 may be formed tissue (e.g., allograft,autograft).

The implant members 1900, 2000 and/or implant cross member 2050 may havea textured exterior. Alternatively, implant members 1900, 2000 and/orimplant cross member 2050 may take the form of a tissue scaffold, forinstance a scaffold constructed using 3-D printing techniques. Suchtextured surface or scaffold may encourage biological overgrowth. Theimplant members 1900, 2000 and/or implant cross member 2050 may carryone or more functional coatings or layers. Such may either encourage orinhibit formation of scarring, may deliver (e.g., elute) a therapeuticagent to the organ or blood. Such may include gold, heparin, carbonnanocomposite, silicon carbide, titanium-nitride-oxide,phosphorylcholine, etc.

FIGS. 21A and 21B show a fastener 2100 that fastens to a guide line suchas a guide wire 2102, according to one illustrated embodiment.

The fastener 2100 has a cavity 2104 which provides a passage through thefastener 2100 for the guide line (e.g., Nitinol wire). The cavity 2104may include openings in two opposed surfaces of the fastener 2100 toprovide a passage for the guide line or guide wire 2102. The cavity 2104may have a sloped wall 2106. The cavity 2104 may contain one or morecams or clutches 2108, for instance a spring 2108 a and ball 2108 b. Theball 2108 b is biased toward the sloped wall 2106 by the spring 2108 a.While illustrated as a coil spring, other types of springs may beemployed. The cam or clutch 2108 may include a seat 2108 c which has astem to retain the spring 2108 a and an aperture or concavity to retainthe ball 2108 b. The ball 2108 b frictionally engages the guide line orguide wire 2102 against the sloped wall 2106 in response to movement ofthe fastener 2100 along the guide line 2102 toward an embedded tissueanchor (not shown in FIG. 21A or 21B). The fastener 2100 may be aunidirectional or a one way fastener or clutch, allowing the fastener2100 to ride or move along the guide line or guide wire 2102 in onedirection, but resisting movement in the opposite direction. Such may beemployed to secure the fastener 2100 against the implant member (notshown in FIG. 21A or 21B) percutaneously, to secure the implant memberto the tissue anchors which are embedded in the tissue. Other cams orclutches may be employed. For instance, an arcuate section pivotallymounted and biased, for example by a leaf spring, to engage the guideline or guide wire, may be used. The fastener 2100 may be comprised of abiocompatible material, for example a metal that does not react withbodily tissues or fluids. The fastener 2100 may include a tubularhousing, which may be cylindrical. An end cap may be secured to thehousing, for example via spot welding. The fastener 2100 may, forexample, have a total volume of 8 cubic millimeters. The ball 2108 bmay, for example, have a diameter of approximately 0.5 mm.

FIGS. 22A and 22B show a fastener 2200 that fastens a guide line 2202 toa tissue anchor 2204, according to another illustrated embodiment.

The fastener 2200 physically interacts with a fastening portion 2206 ofthe tissue anchor 2204. In particular, the fastener 2200 has a slopedouter surface or swaging surface 2208 that is received in a cavity 2210of the fastening portion 2206 of the tissue anchor 2204. Engagement ofthe inner wall forming the cavity 2210 plastically deforms the fastener2200, increasing the frictional force applied to the guide line 2202.Such can secure the fastener 2200 to the tissue anchor 2204 and securethe guide line 2202 to the fastener 2200. The fastener 2200 is abidirectional fastener, resisting movement of the guide line 2202 ineither direction once swaged. Such may be employed to secure thefastener against the implant member in its second configuration (notshown in FIG. 22A or 22B) to secure the implant member to the tissueanchors embedded in the tissue. While illustrated with the fastener 2200having a sloped surface 2208, in some embodiments, the inside wallforming the cavity 2210 may be sloped to achieve a similar result. Thefastener 2200 may include a peripheral flange 2212 to form a head. Thesize of the peripheral flange 2212 may be larger than the openings ofthe implant member that receive the guide lines 2202. The fastener 2200may be comprised of a biocompatible material, for example a metal thatdoes not react with bodily tissues or fluids.

Fasteners other than fasteners 2100, 2200 generally described above maybe employed in various example embodiments. While illustrated asseparate from the implant member, the fasteners may be incorporated intothe implant member. For example, the fasteners 2100, 2200 may be securedto the implant member. For instance, the fasteners 2100, 2200 may besecured in apertures or recesses of the implant member, for example viapress fit, swaging, and/or adhesives, to become an integral part of theimplant member. Alternatively, the fasteners 2100, 2200 may be formed asa unitary, single piece portion of the implant member. For instance, asillustrated in FIG. 22C, a fastener may take the form of a resilientmember, such as a tab or pawl 2250, that extends into the guide linereceiver 2252 of an implant member 2254, and which allows the guide lineto easily advance in one direction but which resists retreat of theguide line in the opposite direction. In each of these examples, apassage through the fastener 2100, 2200, 2250 may serve as the guideline receiver.

FIGS. 24A-24H show an implant member 2400, according to one illustratedembodiment. In particular, FIG. 24A shows the implant member 2400 in afirst configuration that is representative of one of a deliveryconfiguration, an unanchored configuration or an untensionedconfiguration, while FIG. 24B shows the implant member 2400 in a secondconfiguration that is representative of one of an implantableconfiguration, a deployed configuration, an anchored configuration or atensioned configuration.

The implant member 2400 is similar to previously described implantmember 1900 and may be used to reshape, reconfigure and/or reinforce anorifice in bodily tissue. For example, the implant member 2400 may beused to reshape, reconfigure and/or reinforce a valve, for instance anatural valve or an artificial valve. The valve may, for example takethe form of a mitral, tricuspid, pulmonary and/or aortic valve of theheart. Alternatively, the valve may take the form of another valve inanother organ of the body.

The implant member 2400 has a plurality of arcuate segments 2402 a-2402c (collectively 2402). While three segments 2402 are illustrated, theimplant member 2400 may include additional segments. The total number ofsegments 2402 may be based on the size of the valve with which theimplant member 2400 will be used. The total number of segments 2402 mayadditionally or alternatively be based on a largest lateral dimensionthat may be accommodated by a given or desired catheter (i.e., diameterof catheter lumen). For instance, in a manner similar to that describedfor implant member 1900, employing a greater number of segments 2402means that each segment may have a smaller height, while still achievinga desired lateral dimension or height of the overall implant member 2400when in the second configuration.

The segments 2402 are physically coupled to one another, and in at leastsome configurations are articulated for movement with respect to oneanother, for example pivotal movement. The implant member 2400 includesa number of hinges 2404 a, 2404 b (collectively 2404) pivotally couplingneighboring ones of the segments 2402. Each hinge 2404 may include ahinge pin 2406 a, 2406 b (collectively 2406) received via throughholes2408 a, 2408 b (collectively 2408) in the segments 2402. Each hinge pin2406 should be fixedly received in the throughhole 2408 to ensure thatthe hinge pin 2406 does not become dislodged after implantation. Thehinge pin 2406 may be swaged in the throughhole 2408, and mayadditionally or alternatively be fixed using other mechanisms. Thelocations of the hinge pins 2406 of the hinges 2404 may be offset from alongitudinal centerline (i.e., the arc that passes longitudinallythrough the geometric center between the longitudinal arcuate edges) ofthe respective one of the arcuate segments 2402. Alternatively, thehinge pins 2406 may lie along the longitudinal centerline.

The segments 2402 include stops 2409 a-2409 d (collectively 2409)proximate the hinges 2404. The stops 2409 on neighboring ones of thesegments 2402 cooperatively interact by engaging one another to preventthe segments 2402 from being pivoted past a defined angle with respectto one another. The stops 2409 thus serve to restrain the segments 2402from further articulation in one direction. While illustrated as simplecomplementary engagement surfaces, the stops may take other forms. Forexample, stops may take the form of a detent or other lock structure.Stops 2409 may lock the segments 2402 from moving along each of twoopposing directions when the implant member is in the secondconfiguration. Stops 2409 may also provide torsional stiffness to thehinges 2404. Stops 2409 may also impart a greater bending stiffness to aportion of the implant member 2400 in its second configuration than ithas in its first configuration.

As illustrated in FIGS. 24A and 24B, the segments 2402 of the implantmember 2400 may be moved with respect to one another into a firstconfiguration, which in this illustrated embodiment is representative ofa delivery configuration or unanchored configuration or untensionedconfiguration. In the first configuration, the implant member 2400 issized and dimensioned to be deliverable via a catheter. In the firstconfiguration, the implant member 2400 may have an elongated, scalloped,crenulated or serpentine profile, as best illustrated in FIG. 24A. Amaximum longitudinal dimension in the first configuration is relativelylong as compared to the maximum longitudinal dimension in the secondconfiguration. As illustrated in FIGS. 24A and 24B, the segments 2402 ofthe implant member 2400 may be moved with respect to one another intothe second configuration representative of an implantable or deployed oranchored or tensioned configuration. In the second configuration, theimplant member 2400 has an arcuate shape or profile. The arcuate shapeis sized and dimensioned to encompass at least part of an orifice. Forexample, the arcuate shape may be sized and dimensioned to overlie partof an annulus of a mitral valve of a heart. In the second configuration,the dimensions of the implant member 2400 are too large to beaccommodated by a typical catheter sheath. In particular, a lateraldimension or height of the implant member 2400 is too large to bereceived by a lumen of the catheter sheath. Advantageously, thearticulated segments 2402 of implant member 2400 allow implant member2400 to be delivered percutaneously in a first configuration whileassuming a structure in a second configuration that is sufficientlyrigid to affect a shape of the tissue orifice in a desired manner. Inthis example embodiment, implant member 2400 is shown coupled with eachhelical tissue anchors 2418 a, 2418 b and 2418 c (collectively tissueanchors 2418) which have been previously embedded into tissue (notshown).

In a manner similar to other described embodiments, forces or tensionmay be applied to the implant member 2400 at the guide line receivers2410 (one called out in FIG. 24A), for instance via embedded helicaltissue anchors and/or wires and/or sutures (not shown in FIGS. 24A and24B). Such may tension the implant member 2400 into the secondconfiguration (FIG. 24B), while the stops 2409 prevent the segments 2402of implant member 2400 from articulating past the second configuration.Such results in implant member 2400 having a generally rigid structurein the second configuration.

In this illustrated embodiment, implant member 2400 has a plurality oftissue anchor receivers 2412 (two called out in FIG. 24A), each of thetissue anchor receivers 2412 configured to receive or mate with arespective one of the embedded helical tissue anchors 2418 when implantmember is positioned in the second configuration. In this exampleembodiment, each of the guide line receivers 2410 is co-axially alignedwith a respective one of the tissue anchor receivers, although otheralignments may be employed in other example embodiments. As implantmember 2400 travels along the guide lines extending from the embeddedhelical tissue anchors 2418, segments 2402 articulate about respectivehinges 2404 to position the implant member in the second configuration.Tensile forces on the guide lines draw portions of the tissue into whichthe helical tissue anchors 2418 are embedded towards implant member 2400as implant member 2400 transitions into the second configuration.Tensile forces on the guide lines move portions of the tissue into whichrespective ones of the helical tissue anchors 2418 are embedded intolocations where each of the embedded helical tissue anchors 2418 iscoupled with a respective one of the tissue anchor receivers 2412 whenthe implant member 2400 is in the second configuration. In thisillustrated embodiment, various portions of the tissue are moved todesired locations and are maintained in these locations by the couplingof implant member 2400 to the embedded helical tissue anchors 2418 viatissue anchor receivers 2412. In this illustrated embodiment, thecoupled embedded helical tissue anchors 2418 may cause portions of someof the segments 2402 to flex against associated stops 2408. In thisillustrated embodiment, the coupled embedded helical tissue anchors 2418tension implant member 2400 in the second configuration. The tension inthe coupled implant member 2400 in the second configuration may besufficient to reduce a pivoting movement of at least some of thesegments 2402 about their associated hinges 2404 during the recipient'ssubsequent cardiac cycle.

The locations of the embedded tissue anchors 2418 and the locations oftheir respective tissue anchor receivers 2412 can be configured to altera shape of a tissue valve or orifice in a desired manner. For example,FIG. 24C shows each of a first helical tissue anchor 2418 a, a secondhelical tissue anchor 2418 b and a third helical tissue anchor 2418 c(collectively helical tissue anchors 2418) embedded into a respectivelocation about a periphery of an orifice in a tissue 2430. In thisexample embodiment, a location of the embedded third tissue anchor 2418c is laterally offset by a first distance 2444 from a first axis 2440(i.e., shown in broken lines) that extends between a location of theembedded first helical tissue anchor 2418 a and a location of theembedded second helical tissue anchor 2418 b. In this exampleembodiment, helical tissue anchors 2418 are embedded into tissue 2430prior to a coupling with implant member 2400. In this exampleembodiment, the helical tissue anchors 2418 are embedded into tissue2430 that forms part of a heart. Specifically, the helical tissueanchors 2418 are embedded about a mitral annulus 2434 within a leftatrium. In this example embodiment, the location of each of the embeddedhelical tissue anchors 2418 is proximate to mitral annulus 2434. In thisexample embodiment, the location of each of the embedded helical tissueanchors 2418 is proximate to a longitudinal axis of the helical tissueanchor 2418. It is understood that the locations of the embedded helicaltissue anchors 2418 can be specified relative to other datums in otherexample embodiments. In some example embodiments, each of the helicaltissue anchors 2418 is transported sequentially through a catheter toits respective implantation location while in other example embodiments,two or more of the helical tissue anchors 2418 are transported as agroup through a catheter to their respective implantation locations. Insome example embodiments, each helical tissue anchor 2418 is implantedsequentially while in other example embodiments, two or more of thehelical tissue anchors 2418 are implanted at substantially the same timeor concurrently.

FIG. 24D shows implant member 2400 coupled with the helical tissueanchors 2412 after they have been embedded into tissue 2430. Implantmember 2400 is reconfigurable between the first configuration and thesecond configuration and is selected to include at least a first tissueanchor receiver 2412 a corresponding to the first helical tissue anchor2418 a, a second tissue anchor receiver 2412 b corresponding to thesecond helical tissue anchor 2418 b, and a third tissue anchor receiver2412 c corresponding to the third helical tissue anchor 2418 c. Firsttissue anchor receiver 2412 a, second tissue anchor receiver 2412 b andthird tissue anchor receiver 2412 c are collectively referred to astissue anchor receivers 2412. As shown in FIG. 24D, implant member 2400can be selected such that a location of the third tissue anchor receiver2412 c on the implant member 2400 in the second configuration islaterally offset by a second distance 2454 from a second axis 2450(i.e., shown in broken lines) that extends between a location of thefirst tissue anchor receiver 2412 a on the implant member 2400 and alocation of the second tissue anchor receiver 2412 b on the implantmember 2400 such that the second distance 2454 is smaller than the firstdistance 2444. In this example embodiment, the location of each tissueanchor receiver 2412 is proximate to a longitudinal axis of the tissueanchor receiver 2412. It is understood that the locations of the tissueanchor receivers 2412 can be specified relative to other datums in otherexample embodiments.

As shown in FIG. 24D, a coupling between the tissue anchor receivers2418 and the embedded helical tissue anchors 2418 will affect a shape ofthe mitral annulus 2434 which can be used to reposition mitral valveleaflets 2436 relative to one another in a desired way. A couplingbetween the tissue anchor receivers 2412 and the embedded helical tissueanchors 2418 will cause a portion of the tissue 2430 into which thethird helical tissue anchor 2418 c is embedded to move relative toanother portion of the tissue 2430 in a desired way. Other portions ofthe tissue 2430 can be moved in a similar fashion based at least on theselection of an appropriately sized and dimensioned implant member 2400.

The relationship between the locations of the embedded helical tissueanchors 2418 and the locations of the tissue anchor receivers 2412employed to alter a shape of mitral annulus 2434 can be illustrated inother ways. FIG. 24C shows that a circle 2460 (i.e., shown in brokenline) can be dimensioned and sized to pass through the locations of theembedded helical tissue anchors 2418. In this example embodiment, acircumference of circle 2460 is greater than a circumference orperimeter of mitral annulus 2434. FIG. 24D shows that a circle 2470(i.e., shown in broken line) can be dimensioned and sized to passthrough the locations of the tissue anchor receivers 2412 when implantmember 2440 is coupled with the embedded tissue anchors 2418. In thisexample embodiment, circle 2460 has a circumference that is greater thana circumference of circle 2470.

FIGS. 24E and 24F respectively show a portion of a segment 2402 ofimplant member 2400 before and after a coupling with an embedded helicaltissue anchor 2418. Tissue into which helical tissue anchor 2418 isembedded is not shown for clarity. In this illustrated embodiment, aguide line 2416 extends from embedded helical tissue anchor 2418 throughthe tissue anchor receiver 2412 and guide line receiver 2410 of segment2402. Helical tissue anchor 2418 includes seat 2426 that is configuredto mate or engage with tissue anchor receiver 2412. In this illustratedembodiment, seat 2426 and tissue anchor receiver 2412 include matingtapered surfaces. Seat 2426 and helical tissue anchor may be provided asa unitary structure. Alternatively, seat 2426 may be secured to helicaltissue anchor 2418 by variety of methods including adhesives, crimping,and heat fitting, by way of non-limiting example. In this illustratedembodiment, fastener 2420 is provided via guide line 2416 to securesegment 2402 to embedded helical tissue anchor 2418. Unlike otherfasteners employed in other described embodiments that secure an implantmember to the tissue by coupling with a guide line (e.g., fasteners2100, 2200), fastener 2420 couples directly with the embedded helicaltissue anchor 2418 itself as shown in FIG. 24F. In this illustratedembodiment, fastener 2420 includes snap-ring features configured toengage with groove 2421 in embedded helical tissue anchor 2418, althoughother well known securement mechanisms can be employed in other exampleembodiments. Spring 2424 is also provided via guide line 2416 such thatit is captured between fastener 2420 and segment 2402. Spring 2424 canprovide various functions which can include by way of non-limitingexample preloading segment 2402 against the embedded helical tissueanchor 2418 to reduce occurrences of the generation of potentiallyharmful wear particulates, or compensating for component manufacturingor assembly tolerances. Once implant member 2400 is secured to theembedded helical tissue anchor 2418, guide line 2416 can be decoupledfrom the embedded helical tissue anchor 2418. Decoupling can includecutting guide line 2416 or drawing guide line 2416 from an opening inembedded helical tissue anchor 2418 into which guide line 2416 islooped. It is noted that this aspect is not limited to helical tissueanchors such as helical tissue anchors 2418 and that other forms oftissue anchors may be employed. For example, FIGS. 24G and 24Hrespectively show a portion of a segment 2402 of implant member 2400before and after a coupling with a grapple tissue anchor 2500 as peranother example embodiment. Specifically, FIG. 24G shows an explodedisometric view of grapple tissue anchor 2500, the portion of segment2402 and various other components while FIG. 24H shows an assembledisometric view into which grapple tissue anchor 2500 is secured to theportion of segment 2402 of implant member 2400. In this exampleembodiment, grapple tissue anchor 2500 is secured to implant member 2400after grapple tissue anchor 2500 has been implanted or embedded intotissue. Tissue into which grapple tissue anchor 2500 is embedded is notshown for clarity.

Grapple tissue anchor 2500 includes at least two elongate members 2502 aand 2502 b (collectively elongated members 2502). Each of the elongatedmembers 2502 includes a first end 2504, a second end 2506 andintermediate portion 2508 (only one called out in FIG. 24G) positionedalong the elongate member 2502 between its first end 2504 and its secondend 2506. Each of the second ends 2506 includes a tip 2512 shaped topenetrate the tissue. Each of the intermediate portions 2508 of theelongate members 2502 is pivotably coupled together by a pivot 2510. Inthis example embodiment, each of the elongated members 2502 includes anarcuate shaped portion. Specifically, in this example embodiment, eachof the elongated members 2502 includes a portion between pivot member2510 and the second end 2506 of the elongate member that extends alongan arcuate path. In this example embodiment, each of the elongatedmembers 2502 forms a prong.

Pivot member 2510 allows the elongated members 2502 to pivot withrespect to one another to position the tips 2512 spaced relatively apartfrom one another at locations advantageous for penetrating the tissue.Upon further deployment of grapple tissue anchor 2500 into the tissue,the elongated members 2502 are pivoted relative to each other to causetips 2502 to travel along a path through the tissue such that tips 2512are positioned closer to one another than during their initialdeployment into the tissue. This allows grapple tissue anchor 2500 tofirmly anchor into the tissue. FIG. 24G shows the elongate members 2502pivoted to a point where the opposed tips 2512 are spaced such thatgrapple tissue anchor 2500 is not fully deployed into the tissue (again,not shown). FIG. 24H shows the elongate members 2502 pivoted to positionthe opposed tips 2512 such that grapple tissue anchor 2500 is fullydeployed into tissue (again not shown). Those skilled in the art willappreciate that other deployment configurations can be employed by othergrapple tissue anchors employed by various embodiments. For example,each of the elongated members 2502 can be configured to follow adifferent path through tissue during the deployment of the grappletissue anchor 2500 into tissue. In some example embodiments, tips 2512may, or may not overlap when grapple tissue anchor 2500 is fullydeployed into tissue.

In this example embodiment, grapple tissue anchor 2500 is part of atissue anchor system that includes at least one coupler 2530 that isphysically coupled to at least one of the elongated member 2502, the atleast one coupler 2530 being additionally configured to be received byimplant member 2400 when the grapple tissue anchor 2500 is secured toimplant member 2400. In this illustrated embodiment, a guide line 2514extends from each elongated member 2502. As best shown in FIG. 24G, aguide line 2514 a extends from elongate member 2502 a and a guide line2514 b extends from elongate member 2502 b. In this example embodiment,each guide line 2514 is sized to be received through an opening 2516(only one called out in FIG. 24G). In this example embodiment, each ofthe guide lines 2514 a and 2514 b is looped through an associated one ofthe openings 2516 (e.g., eyelet). This allows each of the guide lines2514 to be releasably coupled with an associated one of the elongatedmembers 2502, the coupling being released by simply releasing an end ofthe guide line 2514 to allow it to be extracted through an associatedone of the openings 2516.

In this example embodiment, guide lines 2514 are also each sized to bereceived through tissue anchor receiver 2412 and guide line receiver2410 provided in segment 2402. In this example embodiment, guide lines2514 are received through each of tissue anchor receiver 2412 and guideline receiver 2410 after grapple tissue anchor 2500 is embedded intotissue. In this particular embodiment, the at least one coupler 2530includes a two component seat 2518 that is configured to mate or engagewith tissue anchor receiver 2412 in a similar manner to seat 2426employed by the embodiment illustrated in FIGS. 24E and 24F. Seat 2518includes a first seat component 2518 a coupled to elongated member 2502a and a second seat component 2518 b coupled to elongate member 2502 b.Each component of seat 2518 and an associated one of the elongatedmembers 2502 can be provided in a unitary structure. Alternatively, eachcomponent of seat 2518 may be secured to an associated one of theelongated members 2502 by variety of methods including adhesives,crimping, and heat fitting, by way of non-limiting example. When grappletissue anchor 2500 is deployed into tissue, seat 2518 is configured tomate or engage with tissue anchor receiver 2412 in this illustratedexample embodiment. In this illustrated embodiment, the seat components2518 a and 2518 b include tapered surfaces configured to mate with atapered surface provided by tissue anchor receiver 2412 in a mannersimilar to that employed by the embodiment illustrated in FIGS. 24E and24F.

In this illustrated embodiment, fastener 2520 is provided via guidelines 2514 to secure segment 2402 to embedded grapple tissue anchor2500. Unlike other fasteners employed in other described embodimentsthat secure an implant member to the tissue by coupling with a guideline (e.g., fasteners 2100, 2200), fastener 2520 couples directly withthe embedded grapple tissue anchor 2500 itself as shown in FIG. 24H. Inthis illustrated embodiment, fastener 2520 includes snap-ring featuresconfigured to engage with a portion of groove 2521 provided in each ofthe elongated members 2502, when grapple tissue anchor 2500 is embeddedinto tissue. Spring 2524 is also provided via guide lines 2514 such thatit is captured between fastener 2520 and segment 2402. Spring 2524 canprovide various functions which can include by way of non-limitingexample preloading segment 2402 against the embedded grapple tissueanchor 2500 to reduce occurrences of the generation of potentiallyharmful wear particulates, or compensating for component manufacturingor assembly tolerances. Once implant member 2400 is secured to theembedded grapple tissue anchor 2500, guide lines 2514 can be decoupledfrom the embedded grapple tissue anchor 2500.

The present embodiments are not limited to securing grapple tissueanchor 2500 to articulated implant members such as implant member 2400.Other example embodiments may employ other members or mechanisms tosecure tissue anchors such as grapple tissue anchor 2500 to an implantmember employed in an implant procedure. Without limitation, variouscouplers 2530 can be employed to couple a tissue anchor such as grappletissue anchor 2500 to an implant member. By way of non limiting example,coupler 2530 can include a clamp configured to clamp a portion of theimplant member. Coupler 2530 can include an extension sized to bereceived within an opening provided in an implant member. Coupler 2530can include an expansion member configured to expand and grip one ormore surfaces of an implant member. Coupler 2530 can include acontraction member configured to contract and grip one or more surfacesof an implant member. Coupler 2530 can include detent or a snap-actioncomponent.

FIGS. 25A-25F show an implant member 2600, according to one exampleembodiment. In particular, FIG. 25A shows implant member 2600 in a firstconfiguration that is representative of one of a delivery configuration,an unanchored configuration or an untensioned configuration, while FIG.25B shows implant member 2600 in a second configuration that isrepresentative of one of an implantable configuration, a deployedconfiguration, an anchored configuration or a tensioned configuration.

The implant member 2600 is similar to previously described implantmember 2400 and may be used to reshape, reconfigure and/or reinforce anorifice in bodily tissue. For example, the implant member 2600 may beused to reshape, reconfigure and/or reinforce a valve, for instance anatural valve or an artificial valve. The valve may, for example takethe form of a mitral, tricuspid, pulmonary and/or aortic valve of theheart. Alternatively, the valve may take the form of another valve inanother organ of the body.

The implant member 2600 has a plurality of segments 2602 a-2602 c(collectively 2602). While three segments 2602 are illustrated, theimplant member 2600 may include a different number of segments. Thetotal number of segments 2602 may be based on the size of the valve withwhich the implant member 2600 will be used. The total number of segments2602 may additionally or alternatively be based on a largest lateraldimension that may be accommodated by a given or desired catheter (i.e.,diameter of catheter lumen) or catheter sheath. For instance, in mannersimilar to that described for implant member 2400, employing a greaternumber of segments 2602 means that each segment may have a smallerheight (e.g., height 1922), while still achieving a desired lateraldimension or height of the overall implant member 2600 when in thesecond configuration.

In this embodiment, segment 2602 b includes an arcuate portion lyingsubstantially in a single plane (not shown) as best seen in FIG. 25B. Inthis embodiment, each of segment 2602 a and 2602 c includes a pluralityof arcuate portions. Each of the arcuate portions may lie substantiallyin a different one of a plurality of intersecting planes (not shown).Each of the segments 2602 can be formed by various techniques and fromvarious materials. For example, suitable techniques can includecontrolled bending techniques which are employed to bend segment 2602 babout a single bending axis and which are employed to bend each ofsegments 2602 a and 2602 c about each of a plurality of non-parallelbending axes. The use of non-parallel bending axes may provide numerousadvantages including allowing implant member 2600 to better conform to anon-planar tissue surface when implanted. In this example embodiment,each of the segments 2602 is physically coupled to another of thesegments 2602.

As illustrated in FIG. 25A, the segments 2602 of the implant member 2600may be moved with respect to one another into the first configuration.In the first configuration, the implant member 2600 is sized anddimensioned to be deliverable via a catheter. In the firstconfiguration, the implant member 2600 may have an elongated, scalloped,crenulated or serpentine profile. A maximum longitudinal dimension inthe first configuration is relatively long as compared to the maximumlongitudinal dimension in the second configuration. As illustrated inFIG. 25B, the segments 2602 of the implant member 2600 may be moved withrespect to one another into the second configuration. In the secondconfiguration, the implant member 2600 can have a substantially arcuateshape or profile. In this example embodiment, the arcuate shape is sizedand dimensioned to encompass at least part of an orifice. For example,the arcuate shape may be sized and dimensioned to overlie part of anannulus of a mitral valve of a heart. In the second configuration, thedimensions of the implant member 2600 are too large to be accommodatedby a typical catheter sheath. In particular, a lateral dimension orheight of the implant member 2600 is too large to be received by a lumenof the catheter sheath. Advantageously, the segments 2602 of implantmember 2600 allow implant member 2600 to be delivered percutaneously ina first configuration while assuming a structure in a secondconfiguration that is sufficiently rigid to affect a shape of the tissueorifice in a desired manner.

As shown in FIG. 25B, each of a plurality of tissue anchors 2618 a, 2618b, 2618 c and 2618 d (collectively tissue anchors 2618) are secured toimplant member 2600. In some embodiments, various ones of the tissueanchors 2618 are secured to implant member 2600 when implant member 2600is moved into the second configuration. In some embodiments, variousones of the tissue anchors 2618 are secured to implant member 2600 afterimplant member is delivered percutaneously to a bodily cavity. In thisexample embodiment, various ones of the tissue anchors 2618 are securedto implant member 2600 after the various ones of the tissue anchors 2618have been at least partially embedded into tissue. For clarity ofillustration, tissue is not shown in FIG. 25B. In this exampleembodiment each tissue anchor 2618 is a helical tissue anchor. It isnoted that this embodiment is not limited to helical tissue anchors andthat other types of tissue anchors may be employed. Other exampleembodiments may include barbed tissue anchors (e.g., multi-barbed tissueanchor 808) or grapple tissue anchors (e.g., grapple tissue anchor 2500)by way of non-limiting example.

In this illustrated embodiment, implant member 2600 has a plurality oftissue anchor receivers 2612 a, 2612 b, 2612 c and 2612 d (collectively2612) (best seen in FIG. 25A), each of the tissue anchor receivers 2612configured to receive or mate with a respective one of the tissueanchors 2618 when the tissue anchors 2618 are secured to implant member2600. FIG. 25C shows a partially sectioned exploded view of a portion ofimplant member 2600 positioned between the first configuration and thesecond configuration and prior to a securing of tissue anchors 2618 cand 2618 d to implant member 2600. FIG. 25D shows a partially sectionedview of implant member 2600 in the second configuration. FIG. 25D showsa partially sectioned view of implant member 2600 in which tissueanchors 2618 c, 2618 d are received by respective ones of tissue anchorreceivers 2612 c and 2612 d and are secured to implant member 2600. Inthis embodiment, tissue anchors 2618 a and 2618 b (not shown in FIGS.25C and 25D) have similar structures to that of tissue anchors 2618 cand 2618 d and are received by respective ones of tissue anchorreceivers 2612 a and 2612 b (not shown in FIGS. 25C and 25D) which havesimilar structures to that of tissue anchor receivers 2612 c and 2612 d.Tissue anchors 2618 and/or tissue anchor receivers 2612 having differentstructures may be employed in other example embodiments.

Each tissue anchor 2618 includes a portion 2617 (two called out in eachof FIGS. 25C and 25D) that is configured to mate or engage with arespective one of tissue anchor receivers 2612. Portion 2617 and theother portions of the tissue anchor 2618 may be provided as a unitarystructure. Alternatively, portion 2617 may be a separate component. Aseparate portion 2617 may be secured to other portions of a tissueanchor 2618 by variety of methods including adhesives, crimping, andheat fitting, by way of non-limiting example.

In this embodiment, each of the tissue anchor receivers 2612 includes atleast one alignment surface 2615 (one called out in each of FIGS. 25Cand 25D) arranged to guide portion 2617 of an associated one of thetissue anchors 2618 to a position where the associated one of the tissueanchors 2618 is securable to implant member 2600. In this embodiment,each of the tissue anchor receivers 2612 includes at least one alignmentsurface 2615 arranged to guide portion 2617 of an associated one of thetissue anchors 2618 to a position where the portion 2617 is seatedwithin the tissue anchor receiver 2612. In some example embodiments,each of the at least one alignment surfaces 2615 includes a curvedsurface portion. In some example embodiments, each of the at least onealignment surfaces 2615 includes a tapered, frustoconical or conicalsurface portion. In this illustrated embodiment, each portion 2617 andtissue anchor receiver 2612 includes tapered mating surfaces. In thisexample embodiment, each of the at least one alignment surfaces 2615includes a tapered surface portion that is circumferentially arrangedabout a respective alignment axis 2619 (two called out in each of FIGS.25C and 25D). In this example embodiment, as the respective portion 2617of each tissue anchor 2618 is brought into engagement with the at leastone alignment surface 2615 of an associated one of the tissue anchorreceivers 2612, the at least one alignment surface 2615 engages asurface 2613 (two called out in FIG. 25C, one called out in FIG. 25D) ofthe portion 2617 and guides or orients portion 2617 with respect to thealignment axis 2619 so as to appropriately position portion 2617 forsecurement to the implant member 2600 by coupler 2620 (two called out ineach of FIGS. 25C and 25D). In some example embodiments, otherpositional arrangements may be employed between the at least onealignment surface 2615 and a respective alignment axis 2619. In someexample embodiments, the at least one alignment surface 2615 includes aplurality of surfaces arranged about a respective alignment axis 2619.

In this example embodiment, each of the at least one alignment surfaces2615 is arranged to impede or restrain movement of the respectiveportion 2617 of an associated one of the tissue anchors 2618 along atleast one direction that is perpendicular to the alignment axis 2619associated with the at least one alignment surface 2615 when theassociated one of the tissue anchors 2618 is secured to implant member2600. In this example embodiment, each of the at least one alignmentsurfaces 2615 is arranged to impede or restrain movement of therespective portion 2617 of an associated one of the tissue anchors 2618along at least one direction that is radially oriented to the alignmentaxis 2619 associated with the at least one alignment surface 2615 whenthe associated one of the tissue anchors 2618 is secured to implantmember 2600. In this example embodiment, each of the at least onealignment surfaces 2615 is arranged to impede or restrain movement ofthe respective portion 2617 of an associated one of the tissue anchors2618 along at least one direction that intersects the alignment axis2619 associated with the at least one alignment surface 2615 when theassociated one of the tissue anchors 2618 is secured to implant member2600. Restraining movement along various directions perpendicular to,radial to, or intersecting an alignment axis 2619 corresponding to acoupled tissue anchor 2618 and tissue anchor receiver 2612 may providenumerous advantages including, by way of example, reducing potentialmovement between the coupled tissue anchor 2618 and tissue anchorreceiver 2612 during the recipient's subsequent cardiac cycle which maylead to the formation of potentially harmful wear induced debris. Inthis example embodiment, each of the at least one alignment surfaces2615 is arranged to impede or restrain movement of the respectiveportion 2617 of an associated one of the tissue anchors 2618 along adirection that is parallel to a direction that the alignment axis 2619associated with the at least one alignment surface 2615 extends alongwhen the associated one of the tissue anchors 2618 has been fully seatedin a respective tissue anchor receiver 2612.

In this example embodiment, each alignment axis 2619 is oriented along adirection of relative movement required to break contact between the atleast one alignment surface 2615 of a tissue anchor receiver 2612 andsurface 2613 of portion 2617 of a tissue anchor 2618 that has been fullyreceived in the tissue anchor receiver 2612. In this example embodiment,each alignment axis 2619 is oriented along a direction of relativemovement required to unseat the portion 2617 of a tissue anchor 2618that has been fully seated in a respective tissue anchor receiver 2612.In this example embodiment, once a tissue anchor 2618 is secured to theimplant member 2600 with a respective one of couplers 2620, movement ofthe tissue anchor 2618 along at least one direction of a respective oneof the alignment axes 2619 is impeded. In this example embodiment, oncea tissue anchor 2618 is secured to a tissue anchor receiver 2612 ofimplant member 2600, the tissue anchor 2618 is impeded from moving alongthe alignment axis 2619 of the tissue anchor receiver 2612 to breakcontact with the at least one alignment surface 2615 of the tissueanchor receiver 2612.

In some embodiments, a biasing device (e.g., springs 2424, 2524) may beemployed during the securing of a tissue anchor 2618 to implant member2600. A biasing device may provide various functions which can includeby way of non-limiting example preloading various segments 2602 againstthe tissue anchor 2618 to reduce occurrences of the generation ofpotentially harmful wear particulates, or compensating for componentmanufacturing or assembly tolerances. In this example embodiment,combined biasing and tissue anchor securement capabilities are providedby each of couplers 2620. In a manner similar to previously describedfasteners 2420, 2520 each coupler 2620 includes various resilient firstfingers 2621 (three called out in each of FIGS. 25C and 25D) arranged tosnap into a channel 2622 (one called out in each of FIGS. 25C and 25D)provided in each tissue anchor 2618 to secure the tissue anchor 2618 tothe implant member 2600. In this example embodiment, each coupler 2620includes various resilient second fingers 2623 (three called out in FIG.25C and one called out in FIG. 25D) arranged to provide a biasing forcearranged to preload the respective portion 2617 of a tissue anchor 2618against the at least one alignment surface 2615 of an associated one ofthe tissue anchor receivers 2612 when the tissue anchor 2618 is securedto the implant member 2600. In this example embodiment, each coupler2620 biases respective portions of two coupled segments 2602 togetherwhen the tissue anchor 2618 is secured to the implant member 2600. Ascompared in FIGS. 25C and 25D, each coupler 2620 biases respectiveportions of two coupled segments 2602 together to reduce an axialseparation 2649 therebetween in this example embodiment.

In this example embodiment, when a tissue anchor 2618 is secured toimplant member 2600 by a coupler 2620, each of resilient the first andsecond fingers 2621 and 2623 extends along respective directions havingopposing directional components 2621 a, 2623 a (one of each called outin FIG. 25C) that are each parallel with an extension direction of anassociated one of the alignment axes 2619. Each channel 2622 is locatedon its respective tissue anchor 2618 to cause resilient second fingers2623 to flex and provide a required biasing force when respectiveresilient first fingers 2621 are snapped into the channel 2622 to securethe tissue anchor 2618 to the implant member 2600. In this exampleembodiment, each coupler 2620 is arranged to engage a first portion 2624(two called out in each of FIGS. 25C and 25D) of an associated tissueanchor 2618 to capture a portion of implant member 2600 between thecoupler 2620 and a second portion 2626 (two called out in each of FIGS.25C and 25D) of the tissue anchor 2618 when the tissue anchor 2618 issecured to the implant member. In this example embodiment, therespective second portion 2626 of each tissue anchor 2618 is embeddableinto tissue. In this example embodiment, coupler 2620 is providedseparately from implant member 2600. In some example embodiments, aportion of coupler 2620 and implant member 2600 are provided in aunitary structure. For example, a portion of coupler 2620 and a portionof a segment 2602 or housing 2630 may be provided in a unitarystructure.

Other suitable couplers may be employed to secure a tissue anchor 2618to implant member 2600 in other embodiments. By way of non-limitingexample, a coupler 2620 can include a clamp configured to clamp aportion of implant member 2600 or tissue anchor 2618. Coupler 2620 caninclude an extension sized to be received within an opening provided inimplant member 2600 or tissue anchor 2618. Coupler 2620 can include anexpansion member configured to expand and grip one or more surfaces ofimplant member 2600 or tissue anchor 2618. Coupler 2620 can include acontraction member configured to contract and grip one or more surfacesof implant member 2600 or tissue anchor 2618. Coupler 2620 can include athreaded fastener (e.g., a nut) or a pin-like fastener.

In this example embodiment, one of a plurality of the guide linereceivers 2610 (two called out in FIG. 25C) is provided in each of thetissue anchor receivers 2612. Each of the guide line receivers 2610 issized and dimensioned to allow for the passage of a guide line (notshown in FIG. 25C) therethrough. In a manner similar to that describedin previous embodiments, implant member 2600 may travel via guidelinereceivers 2610 along guide lines extending from tissue anchors 2618 thatare embedded into tissue. Segments 2602 may articulate with respect toone another to position the implant member 2600 in the secondconfiguration during this movement.

In this example embodiment, coupler 2620 is also provided via a guideline (not shown) to secure tissue anchor 2618 to implant member 2600.Unlike other fasteners employed in other described embodiments thatsecure an implant member to the tissue by coupling with a guide line(e.g., fasteners 2100, 2200), each coupler 2620 couples directly with atissue anchor 2618 itself as shown in FIGS. 25B and 25D. Once implantmember 2600 is secured to the tissue anchor 2618, the guide line can bedecoupled from the tissue anchor 2618. Decoupling can include cuttingthe guide line or drawing the guide line from an opening in tissueanchor 2618 through which guide line passes. In this example embodiment,each of the guide line receivers 2610 is co-axially aligned with thealignment axis 2619 of a respective one of the tissue anchor receivers2612, although other alignments may be employed in other exampleembodiments. In some embodiments, one or more of the guide linereceivers 2610 may be located in components other than the tissue anchorreceivers 2612.

In this example embodiment, each tissue anchor receiver 2612 is providedas a separate component from the segments 2602. In some embodiments, oneor more of the tissue anchor receivers 2612 is integrally provided witha segment 2602. In this example embodiment, each tissue anchor receiver2612 is assembled into at least one of a plurality of housings 2630 a,2630 b, 2630 c, 2630 d, 2630 e and 2630 f (collectively 2630) that isphysically coupled to a respective one of the segments 2602 as shown inFIGS. 25A and 25B. An example coupling between segment 2602 c andhousing 2630 f is shown in each of FIGS. 25C and 25D. In thisembodiment, housing 2630 f includes a male coupling element 2605 areceived in a female coupling element 2605 b provided in a segment 2602c. In some embodiments, male coupling element 2605 a may be provided bysegment 2602 c and female coupling element 2605 b may be provided inhousing 2630 f. Male coupling element 2605 a may be fixedly coupled tofemale coupling element 2605 b by various techniques including, by wayof non-limiting example, welding, crimping, and bonding. Variousfixtures or keying elements may be employed to establish a desiredorientation between a housing 2630 and a segment 2602. Other physicalcouplings between various other ones of the segments 2602 and housings2630 can be established using similar or other techniques. In someexample embodiments, a housing 2630 is integrally provided in a segment2602. In some example embodiments, a tissue anchor receiver 2612 isintegrally provided in a housing 2630.

In this example embodiment, each of tissue anchor receivers 2612 a and2612 d is assembled into a single housing 2630 (i.e., a respective oneof housings 2630 a and 2630 f). Each of the tissue anchor receivers 2612a and 2612 d can be fixedly attached into a respective one of housings2630 a and 2630 f by a variety of techniques including by way ofnon-limiting example, welding, crimping, and bonding. In this exampleembodiment, each of tissue anchor receivers 2612 b and 2612 c isassembled into a set of at least two of the housings (i.e., a respectiveone of a first set 2631 of housings 2630 b and 2630 c and a second set2633 of housings 2630 d and 2630 e in this illustrated embodiment).

In this embodiment, various sets of the segments 2602 are provided withthe segments 2602 in a given set physically coupled to one another in amanner that provides articulated movement with respect to one another,for example pivotal movement. In this embodiment, implant member 2600includes a number of pivot joints 2636 and 2638. Pivot joint 2636 isprovided to pivotally couple a first set of segments 2602 made up ofsegments 2602 a and 2602 b. In this example embodiment, each of thesegments 2602 a and 2602 b is pivotable about a pivot axis 2632 a (shownin FIG. 25A) associated with a pivot joint 2636 along a respective firstrotational direction 2636 a towards the other of the segments 2602 a and2602 b and along a respective second rotational direction 2636 b awayfrom the other of the segments 2602 a and 2602 b as implant member 2600is moved between the first configuration and the second configuration.Pivot joint 2638 is provided to pivotally couple a second set ofsegments 2602 made up of segments 2602 b and 2602 c. In this exampleembodiment, each of the segments 2602 b and 2602 c is pivotable about apivot axis 2634 a (shown in FIG. 25A) associated with a pivot joint 2638along a respective first rotational direction 2638 a towards the otherof the segments 2602 b and 2602 c and along a respective secondrotational direction 2638 b away from the other of the segments 2602 band 2602 c as implant member 2600 is moved between the firstconfiguration and the second configuration. In this embodiment each ofthe sets of segments 2602 include a same or common segment (i.e., 2602b). Each of first rotational directions 2636 a and 2638 a is opposite toa respective one of second rotational directions 2636 b and 2638 b. Eachof the first and second rotational directions 2636 a and 2636 brepresented by continuous line arrows in FIG. 25A correspond torotational movements of segment 2602 a relative to segment 2602 b. Eachof the first and second rotational directions 2636 a and 2636 brepresented by broken line arrows in FIG. 25A correspond to rotationalmovements of segment 2602 b relative to segment 2602 a. Each of thefirst and second rotational directions 2638 a and 2638 b represented bycontinuous line arrows in FIG. 25A correspond to rotational movements ofsegment 2602 c relative to segment 2602 b. Each of the first and secondrotational directions 2638 a and 2638 b represented by broken linearrows in FIG. 25A correspond to rotational movements of segment 2602 brelative to segment 2602 c.

In this embodiment, each of the pivot joints 2636, 2638 includes arespective one of pivot members 2632 and 2634. In this exampleembodiment, each of pivot members 2632 and 2634 is a pivot pin sized tobe received in an opening in various ones of the housings 2630. Each oneof pivot members 2632 and 2634 includes a journal surface about whichvarious ones of segments 2602 are guided to rotate or pivot about. Inthis example embodiment, each of the tissue anchor receivers 2612 b and2612 c and a respective one of pivot members 2632 and 2634 forms aunitary structure. In other example embodiments, separate pivot membersand tissue anchor receivers are employed. In this example embodiment,the respective alignment surface 2615 of each of the tissue anchorreceivers 2612 b and 2612 c is positioned radially inboard from ajournal surface of a respective one of pivot members 2632 and 2634.

Each of the pivot members 2632 and 2634 is preferably configured toaxially capture the housings 2630 in a respective one of first set 2631of housings 2630 (i.e., housings 2630 b and 2630 c) and second set 2633of housings 2630 (i.e., housings 2630 d and 2630 e) to reduceoccurrences where the pivot member 2632, 2634 or any of the housings2630 in the respective set becomes dislodged after implantation. Forexample, each of the pivot members 2632 and 2634 may be fixedly coupledto one of the housings 2630 in a respective one of the first and secondsets 2631, 2633 of housings by a number of various techniques including,but not limited to, welding, bonding, and swaging. Each of the pivotmembers 2632 and 2634 may include an obstruction or protruding elementsuch as a flange to capture the other one of the housings 2630 in arespective one of the first and second sets 2631, 2633 of housings 2630.Alternatively, each of the pivot members 2632 and 2634 may employ aplurality of spaced-apart protruding elements arranged to capture eachof the housings 2630 in a respective one of the first and the secondsets 2631, 2633 of housings 2630 while allowing each of the housings2630 to rotate with respect to the pivot member. In this exampleembodiment, each of pivot members 2632 and 2634 is welded to one of thehousings 2630 in a respective one of the first and the second sets 2631,2633 of housings 2630. Each of the pivot members 2632 and 2634 includesa flange 2635 (two called out in FIG. 25C) to capture the other housing2630 in the respective one of the first and the second sets 2631, 2633of housings 2630.

In various example embodiments, at least a first pivot joint employed byimplant member 2600 is arranged such that a pivot axis associated withthe first pivot joint intersects a surface of one of the tissue anchors2618 when the tissue anchor is secured to implant member 2600. Forexample, as shown in FIG. 25D, the pivot axis 2634 a associated withpivot joint 2638 intersects a surface of tissue anchor 2618 c whentissue anchor 2618 c is fully received in tissue anchor receiver 2612 c.As shown in FIG. 25D, the pivot axis 2634 a associated with pivot joint2638 intersects a surface of tissue anchor 2618 c when tissue anchor2618 c is secured to implant member 2600. In this example embodiment,the pivot axis 2632 a associated with pivot joint 2636 (not shown inFIG. 25D) also intersects a surface of tissue anchor 2618 b when tissueanchor 2618 b is fully received in tissue anchor receiver 2612 b or issecured to implant member 2600. In this example embodiment, pivot axis2632 a is parallel to pivot axis 2634 a. In other example embodiments,pivot joints 2636 and 2638 may be arranged such that pivot axis 2632 ais not parallel to pivot axis 2634 a.

As shown in FIG. 25D, the pivot axis 2634 a associated with pivot joint2638 is substantially parallel to the alignment axis 2619 associatedwith tissue anchor receiver 2612 c in this illustrated embodiment. Inthis example embodiment, pivot axis 2634 a and the alignment axis 2619associated with tissue anchor receiver 2612 c are collinear axes.

In this example embodiment, the tissue anchor receivers 2612 and thepivot joints 2636, 2638 are arranged on implant member 2600 such thateach of the pivot axes 2632 a and 2634 a are parallel to at least some,but not all of the alignment axes 2619 associated with the tissue anchorreceivers 2612. For example, as shown in FIG. 25D, the pivot axis 2634 aassociated with pivot joint 2638 is substantially parallel to thealignment axis 2619 associated with tissue anchor receiver 2612 c and isnot parallel with the alignment axis 2619 associated with tissue anchorreceiver 2612 d. In this example embodiment, pivot joint 2638 forms partof an articulable or bendable portion of implant member 2600, thebendable portion arranged to pivotally couple at least one substantiallyrigid portion of implant member 2600 (i.e., a portion including segment2602 b) with at least another substantially rigid portion of implantmember 2600 (i.e., a portion including segment 2602 c and housing 2630f). In this example embodiment, at least a first one of the tissueanchor receivers 2612 (i.e., tissue anchor receiver 2612 d) is locatedin one of the rigid portions while at least a second one of the tissueanchor receivers 2612 (i.e., tissue anchor receiver 2612 c) is locatedin the bendable portion. Other forms of bendable portions may beemployed in other example embodiments.

In some example embodiments, at least a first pivot joint employed byimplant member 2600 is arranged such that a pivot axis associated withthe first pivot joint intersects a minimum cylindrical volume thatcontains one of the tissue anchors 2618 when the tissue anchor ispositioned at a location where the tissue anchor is secured to implantmember 2600. FIG. 25F shows an exploded view of a portion of implantmember 2600 in the second configuration. Specifically, FIG. 25F shows anexploded view of a positioning of pivot joint 2636 when tissue anchor2618 b is received by tissue anchor receiver 2612 b and is secured toimplant member 2600. An exploded view is used in FIG. 25F for clarityand it is understood that all the illustrated components are in securedengagement. In this example embodiment, the pivot axis 2632 a associatedwith pivot joint 2636 intersects a minimum cylindrical volume 2670(i.e., shown in broken lines) that contains tissue anchor 2618 b whentissue anchor 2618 b is positioned in secured engagement with implantmember 2600. In this example embodiment, the minimum cylindrical volume2670 is the smallest cylindrical volume that contains tissue anchor 2618b. In this example embodiment, minimum cylindrical volume 2670 istangentially arranged with various extremities or peripheries of tissueanchor 2618 b. In this example embodiment, each tissue anchor of atleast one of the tissue anchors 2618 (e.g., tissue anchors 2618 a and2618 d) is positioned such that a minimum cylindrical volume 2670 thatcontains the tissue anchor of the at least one of the tissue anchors2618 is not intersected by each of the pivot axes 2632 a and 2634 a whenthe tissue anchors 2618 are secured to implant member 2600.

FIG. 25E shows an exploded isometric view of implant member 2600, tissueanchors 2618 and couplers 2620 in the second configuration (i.e., asviewed in a direction substantially opposite to that shown in FIG. 25B).As shown in FIG. 25E, each of the respective two housings 2630 in eachof the first and the second sets 2631, 2633 of housings 2630 includes arespective set of interlockable elements. In this example embodiment,each of the interlockable elements takes the form of a projection 2640 aor a recess 2640 b (collectively referred to as interlockable elements2640). Each of the projections 2640 a provided in a first set 2641 ofthe interlockable elements 2640 associated with one of the housings 2630in a respective one of the first and the second sets 2631, 2633 ofhousings 2630 is sized and dimensioned to be complementarily received bya respective one of the recesses 2640 b provided in a second set 2643 ofthe interlockable elements 2640 associated with the other housing 2630in the respective one of the first and the second sets 2631, 2633 ofhousings 2630. In this example embodiment, each first set 2641 ofinterlockable elements 2640 and each second set 2643 of interlockableelements 2640 includes plurality of projections 2640 a and plurality ofrecesses 2640 b. Specifically, in this example embodiment, each firstset 2641 of interlockable elements 2640 and each second set 2643 ofinterlockable elements 2640 includes three (3) projections 2640 a andthree (3) recesses 2640 b. Other embodiments may employ other numbers ofprojections 2640 a and recesses 2640 b.

In this example embodiment, each associated pair of the first and thesecond sets 2641, 2643 of interlockable elements 2640 forms part ofrespective holder 2660 that is activatable between a free configurationin which each segment 2602 in a set of pivotally coupled segments 2602is arranged to rotate, turn or pivot (used interchangeably herein)towards and away from another segment 2602 in the set of the pivotallycoupled segments 2602, and a fixed configuration in which the segment2602 in the set of the pivotally coupled segments 2602 is impeded fromrotating, turning or pivoting towards and away from another segment 2602in the set of the pivotally coupled segments with a greater resistancethan when the holder 2660 is in the free configuration.

In this example embodiment, each first set 2641 of interlockableelements 2640 and each second set 2643 of interlockable elements 2640 isintegrally provided in a unitary structure with a respective one of thetwo housings 2630 in a respective one of the first and the second sets2631, 2633 of housings 2630. In this example embodiment, theinterlockable elements 2640 in each associated pair of the first and thesecond sets 2641, 2643 of interlockable elements 2640 are radiallyoriented about a respective one of pivot axes 2632 a and 2634 a. In thisexample embodiment, the interlockable elements 2640 in each associatedpair of the first and the second sets 2641, 2643 of interlockableelements 2640 are circumferentially arranged about a respective one ofpivot members 2632 and 2634. In this example embodiment, theinterlockable elements 2640 in each associated pair of the first and thesecond sets 2641, 2643 of interlockable elements 2640 are radiallyoriented about a respective alignment axis 2619 of a respective one oftissue anchor receivers 2612 b and 2612 c. In some example embodiments,various ones of the projections 2640 a and the recesses 2640 b includevarious surfaces that extend radially towards a respective one of pivotaxis 2632 a and pivot axis 2634 a. An exploded detailed view of thefirst and second sets 2641, 2643 associated with pivot joint 2636 isshown in FIG. 25F.

As shown in FIGS. 25A and 25C, when the implant member 2600 is not inthe second configuration, each holder 2660 is in the free configurationand the various interlockable elements 2640 are not interlocked therebyallowing the opposing sets of projections 2640 a to ride adjacently toone another as the implant member 2600 is moved between the firstconfiguration and the second configuration. In this example embodiment,each of pivot members 2632 and 2634 is appropriately sized anddimensioned to allow for sufficient axial separation between thehousings 2630 in a respective one of the first and the second sets 2631,2633 of housings 2630 to allow end portions of opposing projections 2640a to ride adjacently to one another as the implant member 2600 is movedbetween the first configuration and the second configuration.

In this example embodiment, various ones of the segments 2602 may berotated about respective ones of pivot axes 2632 a and 2634 a to aposition where projections 2640 a in each of the first sets 2641 ofinterlockable elements 2640 are rotationally aligned or approximatelyrotationally aligned with respective ones of the recesses 2640 b in anassociated one of the second sets 2643 of interlockable elements 2640.Further movement of the segments 2602 brings projections 2640 a in eachof the first sets 2641 of interlockable elements 2640 closer torespective ones of the recesses 2640 b in an associated one of thesecond sets 2643 of interlockable elements 2640 to establish interlockedengagement therebetween and activate the holders 2660 into the fixedconfiguration. In this example embodiment, this movement is along adirection having a first directional component 2645 parallel to adirection that a respective one of pivot axes 2632 a and 2634 a extendsalong. As compared with FIG. 25D, an axial separation 2649 between thehousings 2630 d and 2630 e of the second set 2633 shown in FIG. 25Cdecreases when the interlocked engagement is established between theinterlockable elements 2640 associated with housings 2630 d and 2630 e.In this example embodiment, a interlocked engagement between anassociated pair of the first and the second sets 2641, 2643 ofinterlockable elements 2640 is established when at least one segment2602 in a set of pivotally coupled segments 2602 is moved along anassociated one of pivot members 2632 and 2634 to reduce an axialdistance between the pivotally coupled segments 2602.

In this example embodiment, the interlocked engagement between anassociated pair of the first and the second sets 2641, 2643 ofinterlockable elements 2640 occurs at a single rotational positioningbetween the respective segments 2602 that rotationally manipulate theassociated pair of the first and the second sets 2641, 2643 ofinterlockable elements 2640. In this example embodiment, the interlockedengagement between each associated pair of the first and the second sets2641, 2643 of interlockable elements 2640 occurs when the segments 2602are manipulated to position implant member 2600 in the secondconfiguration. In this example embodiment, when the associated pair ofthe first and the second sets 2641, 2643 of interlockable elements 2640of a holder 2660 is positioned in interlocked engagement, the holder2660 is in the fixed configuration and impedes a segment 2602 in a setof pivotally coupled segments 2602 from pivoting towards and away fromanother segment 2602 in the set of the pivotally coupled segments with agreater resistance than when the holder 2660 is in the freeconfiguration.

As best shown in FIG. 25F, each of the projections 2640 a and recesses2640 b associated with pivot joint 2636 includes a truncated triangularshape as each is viewed along a respective direction extending radiallytowards pivot axis 2632 a in this example embodiment. In some exampleembodiments, each of the projections 2640 a and recesses 2640 b has atrapezoidal shape as each is viewed along a respective directionextending radially towards an associated pivot axis. Each of theprojections 2640 a and recesses 2640 b can include other shapesincluding, for example, arcuate and rectangular shapes in other exampleembodiments.

In various example embodiments, at least some of the projections 2640 ain at least one set of an associated pair of the first and the secondsets 2641, 2643 of interlockable elements 2640 are shaped for wedgedengagement with at least some of the recesses 2640 b in the other set ofthe associated pair of the first and the second sets 2641, 2643 ofinterlockable elements 2640. Wedged engagement can occur for example,when at least one projection 2640 a in one set of an associated pair ofthe first and the second sets 2641, 2643 of interlockable elements 2640is shaped to be wedged within a respective one of the recesses 2640 b inthe other set of the associated pair of the first and the second sets2641, 2643 of interlockable elements 2640 when the various interlockableelements 2640 are positioned for interlocking engagement. In thisexample embodiment, each projection 2640 a includes a respective pair ofopposing and non-parallel surfaces 2647 a and 2647 b (collectivelysurfaces 2647) (only one of each called out in FIG. 25F) that arepositioned to be wedged between two opposing surfaces 2648 a and 2648 b(collectively surfaces 2648) (only one of each called out in FIG. 25F)of a respective recess 2640 b when the projection 2640 a and therespective recess 2640 b are moved relatively closer with respect to oneanother along a direction having a first directional component 2645parallel to a direction extended along by pivot axis 2632 a. In thisexample embodiment, the first surface 2647 a is oriented with respect tothe first directional component 2645 by a greater angular amount thanthe second surface 2647 b. In this example embodiment, the secondsurface 2647 b is oriented substantially parallel with respect to thefirst directional component 2645.

In this example embodiment, each recess 2640 b includes a matching setof non-parallel surfaces 2648 a and 2648 b sized to provide the desiredwedging action. Surfaces employing different orientations or shapes maybe employed by recesses 2640 b and/or projections 2640 a in otherexample embodiments. In some example embodiments, the interlockableelements 2640 in associated first and second sets 2641, 2643 ofinterlockable elements 2640 are arranged such that a respective singlesurface of each of two more of the projections 2640 a is brought intowedged engagement with a respective single surface of each of two ormore of the recesses 2640 b. In these example embodiments, the wedgedengagement occurs between the combination of the two more of theprojections 2640 a and the combination of the two or more recesses 2640b unlike a wedged engagement created by the wedging of a singleprojection 2640 a into a single recess 2640 b. It is understood thatother embodiments may employ holders 2660 that include mechanisms otherthan interlockable elements 2640 to impede a segment 2602 in a set ofpivotally coupled segments 2602 from pivoting towards and away fromanother segment 2602 in the set of the pivotally coupled segments with agreater resistance when the holder is in the fixed configuration thanwhen the holder 2660 is in the free configuration. For example, holders2660 including selectively activatable friction members may be used insome embodiments.

In this example embodiment, when the interlockable elements 2640 are notpositioned in interlocked engagement, various ones of the surfaces 2647a can be moved to engage a respective one of a plurality of surfaces2650 (only one called out in FIG. 25F) to act as a stop that restrainsvarious ones of the segments 2602 from being pivoted past a definedangle with respect to one another. In this example embodiment, the stopsserve to restrain the segments 2602 from further articulation in onedirection. In this example embodiment, when the implant member 2600 isin the first configuration (i.e., as shown in FIG. 25A) the stopsconstrain the segments 2604 to pivot along a single direction (i.e.,along a respective one of first rotational directions 2636 a, 2638 a)suitable for moving the implant member 2600 into the secondconfiguration (i.e., as shown in FIG. 25B). In this example embodiment,the stops restrain segments 2602 from pivoting back on themselves (i.e.,along a respective one of second rotational directions 2636 b, 2638 b)when the implant member 2600 is in the first configuration. Theemployment of the stops can provide various advantages including forexample, restraining segments 2602 from pivoting back on themselves tofacilitate the percutaneous manipulation of the implant member 2600 fromthe first configuration to the second configuration within a bodilycavity.

In this example embodiment, various portions of the tissue (not shown inFIGS. 25A-25F) are moved to desired locations and are maintained inthese locations by a physical coupling of implant member 2600 to theembedded tissue anchors 2618 via tissue anchor receivers 2612. In amanner similar to other described embodiments, implant member 2600 maybe delivered via a number of guide lines (not shown) coupled torespective ones of tissue anchors 2618 that have been at least partiallyembedded into tissue about an orifice within a body. Forces or tensionmay be applied to the implant member 2600 through guide line receivers2610, for instance via embedded tissue anchors 2618 and/or guide lines(not shown). As implant member 2600 travels along the guide linesextending from the embedded tissue anchors 2618, segments 2602 pivotabout respective ones of pivot joints 2636, 2638 to position the implantmember 2600 in the second configuration. The locations of the embeddedtissue anchors 2618 can be determined in various manners includingmethods similar to those employed in relation to FIGS. 24C and 24D.

Tensile forces on the guide lines draw portions of the tissue into whichthe tissue anchors 2618 are embedded towards implant member 2600 asimplant member 2600 transitions into the second configuration. Tensileforces on the guide lines move portions of the tissue into whichrespective ones of the tissue anchors 2618 are embedded into locationswhere each of the embedded tissue anchors 2618 is received by arespective one of the tissue anchor receivers 2612.

In this example embodiment, the holders 2660 are moved into the fixedconfiguration to allow the implant member 2600 in the secondconfiguration to form a structure sufficiently rigid to affect a shapeof an orifice in the tissue. In this example embodiment, the tissuecoupled to implant member 2600 via the embedded tissue anchors 2618tensions implant member 2600 in the second configuration.

In various example embodiments, when the implant member 2600 ispositioned in the second configuration, the holders 2660 can be securedin the fixed configuration. In this example embodiment, once the implantmember 2600 is positioned in the second configuration, the interlockableelements 2640 in each associated pair of the first and the second sets2641, 2643 of interlockable elements 2640 are secured in interlockedengagement when a tissue anchor 2618 is received by a tissue anchorreceiver 2612 surrounded by the associated pair of the first and thesecond sets 2641, 2643 of interlockable elements 2640 and the tissueanchor 2618 is secured to the implant member 2600 with a coupler 2620.In this example embodiment, coupler 2620 is arranged to provide abiasing force to maintain the interlockable elements 2640 in theassociated pair of the first and the second sets 2641, 2643 ofinterlockable elements 2640 in interlocked engagement. In this exampleembodiment, each segment 2602 in each set of pivotally coupled segments2602 is impeded from pivoting along a respective one of a firstrotational directions 2636 a, 2638 a towards another segment 2602 in theset of pivotally coupled segments 2602 when the associated pair of thefirst and the second sets 2641, 2643 of interlockable elements 2640 aresecured in interlocked engagement. In this example embodiment, eachsegment 2602 in each set of pivotally coupled segments 2602 is impededfrom pivoting along a respective one of second rotational directions2636 b, 2638 b away from another segment 2602 in the set of pivotallycoupled segments 2602 when the associated pair of the first and thesecond sets 2641, 2643 of interlockable elements 2640 are secured inwedged engagement. A pivot joint can include some amount of radial andaxial play which can lead to movement along various directions which maygenerate dangerous wear debris that enters the recipient's circulatorysystem and potentially increases the occurrence of strokes. In thisexample embodiment, the interlockable elements 2640 and coupler 2620combine to reduce movements associated with each of the pivot joints2636 and 2638.

This illustrated embodiment may provide enhancements over otherdescribed embodiments in which an implant member (e.g., implant members2400, 2500) is secured to previously embedded tissue anchors undertension with various stops (e.g., stops 2409) serving to restrain thesegments of the implant member from further articulation in onerotational direction. In particular, the use of holders 2660 allowsimplant member 2600 to be maintained in its second configuration ifminor tissue forces that act to reduce tension on the implant member2600 arise during or after the remodeling of the orifice.

It is noted that in this example embodiment an associated pair of thefirst and the second sets 2641, 2643 of interlockable elements 2640 ofat least one of the holders 2660 may become interlocked when the implantmember 2600 is in the midst of being positioned between the firstconfiguration and the second configuration. That is, the associated pairof the first and the second sets 2641, 2643 of interlockable elements2640 can become inadvertently interlocked within the bodily cavity priorto a positioning of the implant member 2600 at a desired location on atissue surface having an orifice that is to be remodeled. Additionallyor alternatively, situations may arise where implant member 2600 ispositioned in the second configuration about an orifice on a tissuesurface only to discover that the implant member 2600 is incorrectlysized to remodel the orifice. Since the interlockable elements 2640 areinterlocked when the implant member 2600 is in the second configuration,the interlockable elements 2640 can require disengagement from oneanother before the implant member 2640 can be removed from the bodilycavity and replaced with an appropriately sized version. This can becomeespecially difficult to do when percutaneous techniques are employed.

In this example embodiment, the first surface 2647 a of each projection2640 a is oriented with respect to the first directional component 2645by a sufficient angular amount to facilitate disengagement between firstand the second sets 2641, 2643 of interlockable elements 2640 should aninadvertent engagement occur. In this example embodiment, the firstsurface 2647 a of each projection 2640 a is oriented with respect to thefirst directional component 2645 by an angular amount sufficient toaxially separate a pair of interlocked first and second sets 2641, 2643of interlockable elements 2640 under the application of a force to movean associated one of the segments 2602 along a respective one of secondrotational directions 2636 b, 2638 b to disengage the interlockableelements 2640. The angular amount that the first surface 2647 a of eachprojection 2640 a is oriented with respect to the first directionalcomponent 2645 is however limited to withstand possible tissue forcesthat may act to move the implant member 2600 away from its secondconfiguration when the implant member 2600 is secured to the tissue. Itis noted that a biasing force applied by a biasing element (i.e.,coupler 2620 in this embodiment) can also help to withstand possibletissue forces that may act to move the implant member 2600 away from itssecond configuration when the implant member 2600 is secured to thetissue. In this illustrated embodiment, the first surface 2647 a of eachprojection 2640 a is oriented with respect to the first directionalcomponent 2645 by approximately fifty (50) degrees.

In this example embodiment, each second surface 2647 b is less steeplyinclined with respect to the first directional component 2645 than arespective one of the first surfaces 2647 a to provide implant member2600 with the necessary rigidity to withstand the tissue tension forceswhen the implant member 2600 is secured to the tissue in the secondconfiguration.

Accordingly, in this example embodiment, a first one of two pivotallycoupled segments 2602 is impeded with a first resistance from pivotingabout an associated one of the pivots axes 2632 a and 2634 a along afirst rotational direction (i.e., a respective one of first rotationaldirections 2636 a and 2638 a) towards a second one of the two pivotallycoupled segments 2602 when an associated holder 2660 is in the fixedconfiguration, and the first one of two pivotally coupled segments 2602is impeded with a second resistance from pivoting about an associatedone of the pivots axes 2632 a and 2634 a along a second rotationaldirection (i.e., a respective one of second rotational directions 2636 band 2638 b) away from the second one of the two pivotally coupledsegments 2602 when the associated holder 2660 is in the fixedconfiguration, each of the first resistance and the second resistancebeing provided at least in part by the holder 2660 and a magnitude ofthe second resistance being less than a magnitude of the firstresistance.

FIGS. 23A-23T sequentially show an implant procedure according to oneillustrated embodiment. The implant procedure includes placement oftissue anchors via an anchor guide frame at selected locations in anannulus surrounding a mitral valve of a left atrium of a heart, and thesecurement of an implant member to the annulus via the embedded tissueanchors.

Fluoroscopy, C T scanning, transesophageal echography (TEE) and/or otherimaging or radiological techniques may be employed during all or part ofthe medical procedure, for example for guiding various catheters and/orlocating the anchor guide frame for precisely placing or embedding thetissue anchors. For instance, TEE techniques may be employed todetermine when to lock the implant member in position in the implantableconfiguration with the fasteners. Ultrasound imaging may be employedbefore the medical procedure, or as part of the medical procedure, todetermine a size of the mitral valve. Such information may be employedin selecting an appropriately sized implant member or in adjusting asize of the implant member. In some instances, the implant member mayalso be selected based on the actual locations of the tissue anchors.

In particular, FIG. 23A shows a distal end 2300 of a cardiac cathetersheath 2302 advancing in a left atrium 2304 of a heart. The cardiaccatheter sheath 2302 may, for example, enter the heart via the inferiorvena cava (not shown) or the superior vena cava (not shown), then enterthe left atrium via a hole formed in the septum (not shown) of theheart. The cardiac catheter sheath 2302 may be inserted using anintroducer and guide wire, as is commonly known. A proximate end (notshown) of the cardiac catheter sheath 2302 is outside of the bodily oraccessible from outside of the body.

An engagement or locating member 2306 of an anchor guide frame 2308 isvisible, extending out of the distal end 2300 of the cardiac cathetersheath 2302. The engagement or locating member 2306 may have a number ofarms 2306 a (three illustrated, only one called out in FIGS. 23A-23T)and a hub 2306 b. The hub 2306 b may couple the arms 2306 a. A mitralvalve 2310 of the heart is also visible, including an annulus 2312,which is natural tissue that surrounds the mitral valve 2310. In use,the hub 2306 b may be centered in the mitral valve 2310 in contact withthe cusps or leaflets of the mitral valve 2310. The hub 2306 b may takethe form of an alignment member, for instance the alignment fin 1305previously described with reference to FIG. 13.

FIG. 23B shows an anchoring catheter 2314 extending out of the cardiaccatheter sheath 2302. The anchoring catheter 2314 carries the anchorguide frame 2308. The anchoring catheter 2314 has a steerable portion2315, which may be selectively steered from a location outside the body.The steerable portion 2315 may include an articulated section. Thesteerable portion 2315 may be steered mechanically, for example usingwires (not shown in FIGS. 23A-23T) that extend through the anchoringcatheter 2314 and which are attached to opposing portions of thearticulated section. Alternatively, the steerable portion 2315 may besteered hydraulically, for example by controlling pressure in a numberof lumens that extend through the anchoring catheter and which terminatein the articulated section. In addition to the engagement or locatingmember 2306, the anchor guide frame 2308 includes a number of anchorguides 2316 (three illustrated in FIGS. 23A-23T, only one called out)which guide tissue anchors 2318 (FIGS. 23J-23T) to selected locations onthe annulus 2312. The anchor guides 2316 may each include a dual lumenouter tube 2320 (only one called out in FIGS. 23A-23T). One lumen maycarry a respective one of the arms 2306 a of the engagement or locatingmember 2306 for movement through the lumen. The other lumen may carry aninner or guide tube 2322, the tissue anchor 2318 and a guide line orguide wire 2330 (only one called out in FIGS. 23M-23T) for movementthrough the lumen. The inner or guide tube 2322 may be physicallycoupled to advance the tissue anchor 2318 through the lumen. Such astructure, and its use, were previously explained with reference toFIGS. 8C-8F.

FIG. 23C shows the anchoring catheter 2314 being steered to face themitral valve 2310. FIG. 23D shows the anchoring catheter 2314 beingadvanced toward the mitral valve 2310.

FIG. 23E shows the engagement or locating member 2306 being extendedfrom the anchoring catheter 2314 toward the mitral valve 2310. FIG. 23Fshows the anchor guide frame 2308 beginning to open or expand, a slightbow in arms 2308 a (only one called out in FIGS. 23F-23S) being visiblein FIG. 23F. The anchor guide frame 2308 is opened once the engagementor locating member 2306 or hub 2306 b is approximately in a desiredposition and orientation with respect to the mitral valve 2310. FIGS.23G and 23H show the anchor guide frame 2308 opening or expandingfurther at successive intervals. FIG. 231 shows the anchor guide frame2308 fully open or expanded. The anchor guide frame 2308 may moveautomatically into position because of the correspondence of the shapeof the anchor guide frame 2308 with the anatomical structure of thevalve. The anchor guide frame 2308 may be constructed so that the tworear most arms (as illustrated, one labeled 2306 a and other one at theback of the figure) slide into the mitral commissures. Even if theanchor guide frame 2308 is deployed at the wrong angle, expanding thearms caused the anchor guide frame 2308 to rotate as the arms get pushedinto the commissures. The mitral annulus is not perfectly round, and“corners” of the mitral annulus can advantageously be used to cause theanchor guide frame 2308 to automatically align with the mitral valve.

FIG. 23J shows the inner or guide tubes 2322 with tissue anchors 2318beginning to protrude from the outer tubes 2320. FIGS. 23K and 23L showthe inner or guide tubes 2322 with tissue anchors 2318 protrudingfurther from the outer tubes 2320, at successive intervals, embeddingthe tissue anchors 2318 into the annulus 2312 of the mitral valve 2310.FIG. 23M shows the inner or guide tubes 2322 being withdrawn back intothe outer tubes 2320, leaving the tissue anchors 2318 embedded in thetissue of the annulus 2312. The guide line or guide wire 2330 is firstvisible in FIG. 23M. As explained in reference to FIGS. 8C-8F, the guideline or guide wire 2330 may be pushed or held in place as the inner orguide tubes 2322 are withdrawn back into the outer tube 2320. FIG. 23Nshows the inner or guide tubes 2322 almost fully withdrawn in the outertube 2320, while FIG. 23O shows the inner or guide tubes 2322 fullywithdrawn in the outer tube 2320.

FIG. 23P shows the anchor guide frame 2308 closing or collapsing. FIGS.23Q and 23R shows the closed or collapsed anchor guide frame 2308 andanchoring catheter 2314 being positioned and oriented at successiveintervals to be withdrawn into the cardiac catheter sheath 2302. FIG.23S shows the anchoring catheter 2314 withdrawn into the cardiaccatheter sheath 2302, leaving the tissue anchors 2318 and guide lines orguide wires 2330 behind in the left atrium 2304 of the heart. Theanchoring catheter 2314 may then be removed, clearing the cardiaccatheter sheath 2302 for the next catheter, used to deliver an implantmember. After the anchoring catheter 2314 is withdrawn from the cardiaccatheter sheath 2302, the guide lines or guide wires 2330 extend fromthe tissue anchors 2318 through the cardiac catheter sheath 2302 atleast to the proximate end thereof. Such allows an implant member to becoupled to the guide lines or guide wires 2330.

FIG. 23T shows a portion of an implant member 2332 being advanced intothe left atrium 2304 through the cardiac catheter sheath 2302. Theimplant member 2332 may take the form of an annuloplasty ring. As usedherein and in the claims, a ring or annular structure may be an openstructure (e.g., C-shaped) or a closed structure (e.g., O-shaped orD-shaped). The implant member 2332 has a number of guide line receivers2332 a (only one illustrated in FIG. 23T) that couple the implant member2332 to a respective guide line or guide wire 2330. In the illustratedembodiment, the guide line receiver 2332 a takes the form of a hole oraperture, sized to receive the guide line or guide wire 2330. Suchallows the implant member 2332 to ride or otherwise advance along theguide lines or guide wires 2330 toward the tissue anchors 2318 embeddedin the tissue around an orifice (e.g., mitral valve 2310). As previouslyexplained in reference to FIGS. 5C and 5D, the implant member 2332 mayinclude a relief (not illustrated in FIG. 23T) proximate the guide linereceiver 2332 a.

FIG. 23U shows the implant member 2332, guide lines or guide wires 2318and fasteners 2334 (only one called out in FIG. 23U), according to oneillustrated embodiment.

The implant member 2332 takes the form of an annuloplasty ring. Suitablesegmented structures for the implant member 2332 have been previouslydescribed, for example in reference to FIGS. 19A-19D, 20A-20D, 24A-24Hand 25A-25F although other implant member structures may be employed.The implant member 2332 is physically attached directly or coupledindirectly to the annulus 2312 of the mitral valve 2310. The implantmember 2332 encompasses or surrounds a portion of the mitral valve 2310,for example angularly surrounding approximately half of the mitral valve2310. In particular, the implant member 2332 is positioned and orientedto allow an anterior-posterior annular dimension of the mitral valve2310 to be changed, for instance reduced. Such may cause the leaflets ofthe mitral valve 2310 to better coapt.

The implant member 2332 may ride or otherwise advance along the guidelines or guide wires 2318 to the locations on the annulus 2312 where thetissue anchors 2318 are embedded. A desired position and orientation isachieved due to the ability to precisely locate the tissue anchors 2318using the anchor guide frame 2308. In particular, the engagement orlocating member 2306 or hub 2306 b and/or the anchor guides 2316 allowsprecise positioning and orientation of the embedding of the tissueanchors 1218, and hence the precise positioning and orientation of theimplant member 2332.

In this example embodiment, fasteners 2334 are advanced along each ofthe guide lines or guide wires 2330 to secure the implant member 2332 tothe annulus 2312. As previously described, the fasteners 2334 may take avariety of forms. For example, one-way clutch or cam mechanisms mayallow the fasteners 2334 to advance in one direction along the guidelines or guide wires 2330 toward the tissue anchors 2318, but prevent orresist retreat of the fasteners 2334 along the guide lines or guidewires 2330 away from the tissue anchors 2318. After the fasteners 2334are in place, excess portions of the guide lines or wires 2330 may becut, broken or otherwise severed, and the excess portions removed fromthe body via the cardiac catheter sheath 2302. Various embodiments ofsuitable cutting or severing mechanisms have been described above.Alternatively, a mechanism that facilitates a twisting or flexing of theguide lines or guide wires 2330 may be employed. The guide lines orguide wires 2330 are typically very fine, and may be easily severed withappropriate twisting or rotation about a longitudinal axis thereof. Asmall tail piece of guide line or guide wire 2330 may be left exposedbeyond the fastener 2334 to allow later access, for example to replacethe implant member 2332. In other example embodiments, fasteners 2334are employed to couple directly with the embedded tissue anchors 2318 tosecure implant member 2332 to the annulus 2312. In some exampleembodiments implant member 2332 and fasteners 2334 are combined into aunitary structure.

The various embodiments described above can be combined to providefurther embodiments. All of any U.S. patents, U.S. patent applicationpublications, U.S. patent applications, foreign patents, foreign patentapplications and non-patent publications referred to in thisspecification and/or listed in the Application Data Sheet, includingU.S. provisional patent application Ser. No. 61/278,232, filed Oct. 1,2009, and U.S. patent application Ser. No. 12/894,912, filed Sep. 30,2010 are incorporated herein by reference, in their entirety. Aspects ofthe various embodiments can be modified, if necessary, to employsystems, circuits and concepts of the various patents, applications andpublications to provide yet further embodiments.

These and other changes can be made in light of the above-detaileddescription. In general, in the following claims, the terms used shouldnot be construed to limit the invention to the specific embodimentsdisclosed in the specification and the claims, but should be construedto include all medical treatment devices in accordance with the claims.Accordingly, the invention is not limited by the disclosure, but insteadits scope is to be determined entirely by the following claims.

1. An implant kit, comprising: a plurality of tissue anchors configuredto be at least partially embedded into tissue at respective locationsabout an orifice within a body during an implant procedure; and animplant member reconfigurable between a delivery configuration in whichthe implant member is manipulable to a size and dimension to bedelivered percutaneously to the tissue within the body, and a deployedconfiguration in which the implant member forms a structure sufficientlyrigid to affect a shape of the orifice in the tissue, the implant membercomprising: a plurality of segments; a number of pivot joints, eachpivot joint comprising a respective pivot pin and a respective pivotaxis, the pivot pin of each pivot joint arranged to pivotally coupleeach of the segments together in a respective one of a number of sets oftwo or more of the segments, at least one segment in each respective oneof the number of sets of two or more of the segments pivoting about therespective pivot axis of the pivot joint when the implant member ismoved between the delivery configuration and the deployed configuration;and a plurality of tissue anchor receivers, each tissue anchor receivercomprising at least one alignment surface arranged to contact a portionof a respective one of the plurality of tissue anchors and align theportion of the respective one of the plurality of tissue anchors withrespect to an alignment axis of the tissue anchor receiver when therespective one of the plurality of tissue anchors is secured to theimplant member, the portion of the respective one of the plurality oftissue anchors impeded from moving along the alignment axis of thetissue anchor receiver to break contact with the at least one alignmentsurface of the tissue anchor receiver when the respective one of theplurality of tissue anchors is secured to the implant member, whereinthe respective alignment axis of at least a first one of the pluralityof tissue anchor receivers is non-parallel with the respective pivotaxis of at least one of the number of pivot joints, and wherein therespective alignment axis of at least a second one of the plurality oftissue anchor receivers is substantially parallel to the respectivepivot axis of the at least one of the number of pivot joints.
 2. Theimplant kit of claim 1 wherein the respective at least one alignmentsurface of each tissue anchor receiver is arranged to impede the portionof the respective one of the plurality of tissue anchors from movingalong a direction having a directional component perpendicular to therespective alignment axis of the tissue anchor receiver when therespective one of the plurality of tissue anchors is secured to theimplant member.
 3. The implant kit of claim 1 wherein at least one ofthe plurality of tissue anchors is embedded in the tissue when therespective portion of the at least one of the plurality of tissueanchors is aligned by the at least one alignment surface of a respectiveone of the plurality of tissue anchor receivers.
 4. The implant kit ofclaim 1 wherein at least one of the plurality of tissue anchors isembedded in the tissue when the at least one of the plurality of tissueanchors is secured to the implant member.
 5. The implant kit of claim 4,further comprising a number of implant guide lines, each of the numberof implant guide lines physically coupled to the at least one of theplurality of tissue anchors when the at least one of the plurality oftissue anchors is embedded in the tissue to provide a physical path forthe implant member to the at least one of the plurality of tissueanchors, the implant member moveable along the physical path to aposition where the implant member is secured to the at least one of theplurality of tissue anchors.
 6. The implant kit of claim 1 wherein thenumber of pivot joints comprises a plurality of pivot joints arrangedsuch that the respective pivot axes of at least two of the plurality ofpivot joints are parallel with respect to one another.
 7. The implantkit of claim 1 wherein the number of pivot joints comprises a pluralityof pivot joints arranged such that the respective pivot axes of at leasttwo of the plurality of pivot joints are non-parallel with respect toone another.
 8. The implant kit of claim 1, further comprising aplurality of biasing devices, each of the biasing devices biasing thesegments together in a respective one of the number of sets of two ormore of the segments when the plurality of tissue anchors are secured tothe implant member.
 9. The implant kit of claim 1, further comprising aplurality of couplers, each coupler arranged to engage a respectivefirst portion of a respective one of the plurality of tissue anchors tocapture a portion of the implant member between the coupler and arespective second portion of the respective one of the plurality oftissue anchors when the respective one of the plurality of tissueanchors is secured to the implant member, the respective second portionof each of the plurality of tissue anchors embeddable into the tissue.10. The implant kit of claim 1, further comprising a number of holders,each holder activatable between a free configuration in which eachsegment in a respective one of the number of sets of two or more of thesegments is arranged to pivot towards and away from another one of thesegments in the respective one of the number of sets of two or more ofthe segments, and a fixed configuration in which the segment in therespective one of the number of sets of two or more of the segments isimpeded from pivoting towards and away from the another one of thesegments in the respective one of the number of sets of two or more ofthe segments with a greater resistance than when the holder is in thefree configuration.
 11. The implant kit of claim 10 wherein each holdercomprises a respective plurality of interlockable elements which arebrought into interlocked engagement when the implant member is movedinto the deployed configuration.
 12. The implant kit of claim 11 whereineach of the plurality of interlockable elements comprises a trapezoidalshaped projection or a trapezoidal shaped recess.
 13. The implant kit ofclaim 1 wherein the respective alignment axis of at least the second oneof the plurality of tissue anchor receivers is collinear with therespective pivot axis of the at least one of the number of pivot joints.14. An implant kit, comprising: a plurality of tissue anchors, each ofthe plurality of tissue anchors at least partially embeddable intotissue at a respective location about an orifice within a body during animplant procedure; and an implant member reconfigurable between adelivery configuration in which the implant member is manipulable to asize and dimension to be delivered percutaneously to the tissue withinthe body, and a deployed configuration in which the implant member formsa structure sufficiently rigid to affect a shape of the orifice in thetissue, the implant member comprising: a plurality of segments; aplurality of tissue anchor receivers, each tissue anchor receivercomprising at least one alignment surface arranged to contact a portionof a respective one of the plurality of tissue anchors and position theportion of the respective one of the plurality of tissue anchors at alocation where the one of the plurality of tissue anchors is securableto the implant member; and at least a first pivot joint comprising afirst pivot member, the first pivot joint arranged to pivotally couple afirst set of two or more of the segments together, at least some of thesegments in the first set of two or more of the segments arranged toturn about the first pivot member when the implant member is movedbetween the delivery configuration and the deployed configuration, thefirst pivot member and a first one of the tissue anchor receiversprovided in a unitary structure.
 15. The implant kit of claim 14 whereinthe first pivot member is fixedly coupled to one of the segments in thefirst set of two or more of the segments.
 16. The implant kit of claim14 wherein at least one segment in the first set of two or more of thesegments is slidably and pivotably coupled to the first pivot member,the at least one segment in the first set of two or more of the segmentsarranged to translate along, and turn about, the first pivot member whenthe implant member is moved between the delivery configuration and thedeployed configuration.
 17. The implant kit of claim 16 wherein thefirst pivot member comprises at least one obstruction positioned tocapture the at least one segment in the first set of two or more of thesegments on the first pivot member.
 18. The implant kit of claim 14wherein the respective at least one alignment surface of the first oneof the tissue anchor receivers is radially spaced apart from a pivotaxis of the first pivot joint by a different radial distance than asurface of the first pivot member contacted by the at least some of thesegments in the first set of two or more of the segments.
 19. Theimplant kit of claim 18 wherein the respective at least one alignmentsurface of the first one of the tissue anchor receivers comprises atapered surface portion.
 20. The implant kit of claim 14 wherein theimplant member comprises a plurality of interlockable elements arrangedabout a pivot axis of the first pivot joint, a first set of theinterlockable elements arranged to interlock with a second set ofinterlockable elements when the implant member is in the deployedconfiguration.
 21. An implant kit, comprising: a plurality of tissueanchors, each of the plurality of tissue anchors at least partiallyembeddable into tissue at a respective location about an orifice withina body during an implant procedure; and an implant member reconfigurablebetween a delivery configuration in which the implant member ismanipulable to a size and dimension to be delivered percutaneously tothe tissue within the body, and a deployed configuration in which theimplant member forms a structure sufficiently rigid to affect a shape ofthe orifice in the tissue, the implant member comprising: a plurality ofrigid portions; at least one bendable portion arranged to pivotallycouple at least one of the rigid portions with at least another of therigid portions; and a plurality of tissue anchor receivers, each tissueanchor receiver comprising at least one alignment surface arranged tocontact a portion of a respective one of the plurality of tissue anchorsand position the portion of the respective one of the plurality oftissue anchors at a location where the one of the plurality of tissueanchors is securable to the implant member, at least a first one of theplurality of tissue anchor receivers located in one of the plurality ofrigid portions and at least a second one of the plurality of tissueanchor receivers located in the at least one bendable portion.